The following data is part of a premarket notification filed by Advantage Medical Systems, Inc. with the FDA for Model Pm-20a Physiological Monitor.
| Device ID | K880756 |
| 510k Number | K880756 |
| Device Name: | MODEL PM-20A PHYSIOLOGICAL MONITOR |
| Classification | Oximeter |
| Applicant | ADVANTAGE MEDICAL SYSTEMS, INC. 925 SHERMAN AVE. Hamden, CT 06514 |
| Contact | Anthony Calderoni |
| Correspondent | Anthony Calderoni ADVANTAGE MEDICAL SYSTEMS, INC. 925 SHERMAN AVE. Hamden, CT 06514 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-25 |
| Decision Date | 1988-09-27 |