K782033 is an FDA 510(k) clearance for the CARDIAC CARE Q/C TEST KIT. This device is classified as a Tester, Defibrillator (Class II - Special Controls, product code DRL).
Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on December 15, 1978, 9 days after receiving the submission on December 6, 1978.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5325.
| 510(k) Number | K782033 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 1978 |
| Decision Date | December 15, 1978 |
| Days to Decision | 9 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DRL — Tester, Defibrillator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5325 |