The following data is part of a premarket notification filed by Nasiff Assoc., Inc. with the FDA for Cardio-card Management System Ii.
| Device ID | K972795 |
| 510k Number | K972795 |
| Device Name: | CARDIO-CARD MANAGEMENT SYSTEM II |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | NASIFF ASSOC., INC. 9422 LEBEAU LN. Brewerton, NY 13029 |
| Contact | Roger E Nasiff |
| Correspondent | Roger E Nasiff NASIFF ASSOC., INC. 9422 LEBEAU LN. Brewerton, NY 13029 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-28 |
| Decision Date | 1998-02-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G466CUSBNIBP0 | K972795 | 000 |