The following data is part of a premarket notification filed by Nicolet Biomedical Instruments with the FDA for Nic-200 Ventricular Function Analyzer.
| Device ID | K792466 |
| 510k Number | K792466 |
| Device Name: | NIC-200 VENTRICULAR FUNCTION ANALYZER |
| Classification | Phonocardiograph |
| Applicant | NICOLET BIOMEDICAL INSTRUMENTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DQC |
| CFR Regulation Number | 870.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-12-03 |
| Decision Date | 1980-01-24 |