K830149 is an FDA 510(k) clearance for the IL VIDEO 22,21 & II ATOMIC SPECTROPHOTO-. This device is classified as a Suction Control, Intracardiac, Cardiopulmonary Bypass (Class II - Special Controls, product code DWD).
Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on February 28, 1983, 42 days after receiving the submission on January 17, 1983.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 870.4430.
| 510(k) Number | K830149 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 17, 1983 |
| Decision Date | February 28, 1983 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | DWD — Suction Control, Intracardiac, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4430 |