The following data is part of a premarket notification filed by Advantage Medical Systems, Inc. with the FDA for Neonatal Physiological Monitor Model Pm 20.
| Device ID | K863494 |
| 510k Number | K863494 |
| Device Name: | NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20 |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| 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 | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-09 |
| Decision Date | 1986-12-22 |