The following data is part of a premarket notification filed by Nasiff Assoc., Inc. with the FDA for Cardio-card Holter Ecg Management System.
| Device ID | K960544 |
| 510k Number | K960544 |
| Device Name: | CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEM |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | NASIFF ASSOC., INC. 9422 LEBEAU LN. P.O. BOX 88 Brewerton, NY 13029 |
| Contact | Roger E Nasiff |
| Correspondent | Roger E Nasiff NASIFF ASSOC., INC. 9422 LEBEAU LN. P.O. BOX 88 Brewerton, NY 13029 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-07 |
| Decision Date | 1996-08-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G466CUSBHOLT0 | K960544 | 000 |