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
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