K781501 is an FDA 510(k) clearance for the ENZAC INCUBATOR. This device is classified as a Block, Heating (Class I - General Controls, product code JRG).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on October 3, 1978, 34 days after receiving the submission on August 30, 1978.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2050.
| 510(k) Number | K781501 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 1978 |
| Decision Date | October 03, 1978 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JRG — Block, Heating |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2050 |