The following data is part of a premarket notification filed by Impact Instrumentation, Inc. with the FDA for Uni-vent(tm) Impact Minute Volume Ventilator.
| Device ID | K870861 |
| 510k Number | K870861 |
| Device Name: | UNI-VENT(TM) IMPACT MINUTE VOLUME VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | IMPACT INSTRUMENTATION, INC. P.O. BOX 508 West Caldwell, NJ 07006 |
| Contact | Leslie H Sherman |
| Correspondent | Leslie H Sherman IMPACT INSTRUMENTATION, INC. P.O. BOX 508 West Caldwell, NJ 07006 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-03 |
| Decision Date | 1988-01-19 |