The following data is part of a premarket notification filed by Timex Medical Products Corp. with the FDA for Healthcheck Auto Inflate Digital Bp.
Device ID | K840228 |
510k Number | K840228 |
Device Name: | HEALTHCHECK AUTO INFLATE DIGITAL BP |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | TIMEX MEDICAL PRODUCTS CORP. 803 N. Front St. Suite 3 McHenry, IL 60050 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-01-20 |
Decision Date | 1984-05-09 |
Severity: Core Warning
Message: Module 'zip' already loaded
Filename: Unknown
Line Number: 0
Backtrace: