The following data is part of a premarket notification filed by Impact Instrumentation, Inc. with the FDA for Uni-vent Model 730aev (automatic Emergency Ventilator).
| Device ID | K032386 |
| 510k Number | K032386 |
| Device Name: | UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR) |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | IMPACT INSTRUMENTATION, INC. 27 FAIRFIELD PL. P.O. BOX 508 West Caldwell, NJ 07006 -0508 |
| Contact | Leslie H Sherman |
| Correspondent | Leslie H Sherman IMPACT INSTRUMENTATION, INC. 27 FAIRFIELD PL. P.O. BOX 508 West Caldwell, NJ 07006 -0508 |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-04 |
| Decision Date | 2004-03-26 |
| Summary: | summary |