The following data is part of a premarket notification filed by Timex Medical Products Corp. with the FDA for Timex Healthcheck Digital Bp Monitor.
| Device ID | K841616 |
| 510k Number | K841616 |
| Device Name: | TIMEX HEALTHCHECK DIGITAL BP MONITOR |
| 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 | 1984-05-01 |
| Decision Date | 1984-06-05 |