Device
HX-461 applies the oscillometric method to measure patient blood pressure. It is composed of blood pressure module, cuff, LCD touch pad control panel and CPU processer based on Win...
Manufacturer
SEERS.Co.,Ltd
SEERS.Co.,Ltd
Model: HX-461
DI: 08800096401772
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-13
Current Version: 2026-05-21
Description
HX-461 applies the oscillometric method to measure patient blood pressure. It is composed of blood pressure module, cuff, LCD touch pad control panel and CPU processer based on Window CE to operate the blood pressure module. Patient can easily operate the device with the touch pad using the cuff installed in the device. Operator can control by touch screen based on SEERS Co.,Ltd.'s software. It has unique communication function that can get the medical information from other blood pressure meter, blood glucose meter and body fat measurement device using bluetooth module and wire connector. HX-461 has a wire and wireless internet function.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
01da2b7c-96a3-4fd5-8968-3928b47a786c
Distribution Status:
In Commercial Distribution
DUNS Number:
557812763
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
08800096401772
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 36551
Name: Patient monitoring system module, blood pressure, noninvasive
Definition:
A small unit dedicated to the measurement of noninvasive blood pressure (indirect method) obtained through a standard sphygmomanometer cuff placed on the arm or leg. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the blood pressure parameter/information measured and provided by this module.
FDA Product Codes
DXN
System, Measurement, Blood-Pressure, Non-Invasive
Premarket Submissions
Submission Number:
K120545
Supplement Number:
000