The following data is part of a premarket notification filed by Ackrad Laboratories with the FDA for Nicos (non-invasive Cardiac Output System).
| Device ID | K904499 |
| 510k Number | K904499 |
| Device Name: | NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM) |
| Classification | Antiserum, Positive Control, Aspergillus Spp. |
| Applicant | ACKRAD LABORATORIES 70 JACKSON DR. Cranford, NJ 07016 |
| Contact | Bernard Ackerman |
| Correspondent | Bernard Ackerman ACKRAD LABORATORIES 70 JACKSON DR. Cranford, NJ 07016 |
| Product Code | KFG |
| CFR Regulation Number | 866.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-01 |
| Decision Date | 1991-07-01 |