K861272 is an FDA 510(k) clearance for the IMPACT MODELS 701, 702 AND 703. This device is classified as a Ventilator, Emergency, Powered (resuscitator) (Class II - Special Controls, product code BTL).
Submitted by Impact Instrumentation, Inc. (Bogota, US). The FDA issued a Cleared decision on May 20, 1986, 46 days after receiving the submission on April 4, 1986.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5925.
| 510(k) Number | K861272 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 1986 |
| Decision Date | May 20, 1986 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BTL — Ventilator, Emergency, Powered (resuscitator) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5925 |