The following data is part of a premarket notification filed by Pearce Clinical Laboratories, Inc. with the FDA for Hypertension Risk Detector(tm).
| Device ID | K871482 |
| 510k Number | K871482 |
| Device Name: | HYPERTENSION RISK DETECTOR(TM) |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | PEARCE CLINICAL LABORATORIES, INC. 805 NO. SAN JACINTO Conroe, TX 77301 |
| Contact | Beth Martin |
| Correspondent | Beth Martin PEARCE CLINICAL LABORATORIES, INC. 805 NO. SAN JACINTO Conroe, TX 77301 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-14 |
| Decision Date | 1987-06-05 |