The following data is part of a premarket notification filed by Nasiff Assoc., Inc. with the FDA for Micromed Qrs Card.
Device ID | K903722 |
510k Number | K903722 |
Device Name: | MICROMED QRS CARD |
Classification | Electrocardiograph |
Applicant | NASIFF ASSOC., INC. P.O. BOX 88 Brewerton, NY 13029 |
Contact | Roger E Nasiff |
Correspondent | Roger E Nasiff NASIFF ASSOC., INC. P.O. BOX 88 Brewerton, NY 13029 |
Product Code | DPS |
CFR Regulation Number | 870.2340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-15 |
Decision Date | 1990-12-05 |