K770914 is an FDA 510(k) clearance for the INCUBATOR, PORTABLE, ACT-STAT. This device is classified as a Instrument, Coagulation (Class II - Special Controls, product code KQG).
Submitted by Thermolyne Corp. (Mchenry, US). The FDA issued a Cleared decision on August 4, 1977, 77 days after receiving the submission on May 19, 1977.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5400.
| 510(k) Number | K770914 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 19, 1977 |
| Decision Date | August 04, 1977 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | KQG — Instrument, Coagulation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5400 |