K941871 is an FDA 510(k) clearance for the LSPI AUTOMATIC VENTILATOR, MODEL AV3000-100. This device is classified as a Ventilator, Emergency, Powered (resuscitator) (Class II - Special Controls, product code BTL).
Submitted by Life Support Products, Inc. (Saint Louis, US). The FDA issued a Cleared decision on January 9, 1995, 266 days after receiving the submission on April 18, 1994.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5925.
| 510(k) Number | K941871 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 18, 1994 |
| Decision Date | January 09, 1995 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BTL — Ventilator, Emergency, Powered (resuscitator) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5925 |