The following data is part of a premarket notification filed by Impact Instrumentation, Inc. with the FDA for Uni-vent 731 Series Model Emv+ Portable Critical Care Ventilator.
| Device ID | K103318 |
| 510k Number | K103318 |
| Device Name: | UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | IMPACT INSTRUMENTATION, INC. 27 FAIRFIELD PL. P.O. BOX 508 West Caldwell, NJ 07006 -0508 |
| Contact | Susan Mcnevin |
| Correspondent | Susan Mcnevin IMPACT INSTRUMENTATION, INC. 27 FAIRFIELD PL. P.O. BOX 508 West Caldwell, NJ 07006 -0508 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-12 |
| Decision Date | 2011-04-07 |
| Summary: | summary |