The following data is part of a premarket notification filed by Namic with the FDA for Perceptor Compensator Morse Manifold.
| Device ID | K951722 |
| 510k Number | K951722 |
| Device Name: | PERCEPTOR COMPENSATOR MORSE MANIFOLD |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | NAMIC PRUYNS ISLAND Glens Falls, NY 12801 |
| Contact | Mary M Rubin |
| Correspondent | Mary M Rubin NAMIC PRUYNS ISLAND Glens Falls, NY 12801 |
| Product Code | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-14 |
| Decision Date | 1996-03-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10193489079029 | K951722 | 000 |
| 20193489065722 | K951722 | 000 |
| 20193489065739 | K951722 | 000 |
| 20193489065746 | K951722 | 000 |
| 20193489065760 | K951722 | 000 |
| 20193489065777 | K951722 | 000 |
| 20193489065791 | K951722 | 000 |
| 20193489065807 | K951722 | 000 |
| 10193489066685 | K951722 | 000 |
| 10193489066692 | K951722 | 000 |
| 10193489066708 | K951722 | 000 |
| 10193489066715 | K951722 | 000 |
| 10193489067194 | K951722 | 000 |
| 10193489067200 | K951722 | 000 |
| 10193489079012 | K951722 | 000 |
| 20193489065715 | K951722 | 000 |