The following data is part of a premarket notification filed by Precision Health Care Systems, Inc. with the FDA for Rhythmscan Precision 6000.
| Device ID | K914577 |
| 510k Number | K914577 |
| Device Name: | RHYTHMSCAN PRECISION 6000 |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | PRECISION HEALTH CARE SYSTEMS, INC. 3541 LOMITA BLVD. Torrance, CA 90505 |
| Contact | Maha Sadras |
| Correspondent | Maha Sadras PRECISION HEALTH CARE SYSTEMS, INC. 3541 LOMITA BLVD. Torrance, CA 90505 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-15 |
| Decision Date | 1992-05-08 |