The following data is part of a premarket notification filed by Impact Instrumentation, Inc. with the FDA for Uni-vent-731 Series Ventilators, Model 731emv+.
Device ID | K091238 |
510k Number | K091238 |
Device Name: | UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+ |
Classification | Ventilator, Continuous, Facility Use |
Applicant | IMPACT INSTRUMENTATION, INC. 27 FAIRFIELD PL. West Caldwell, NJ 07006 -0508 |
Contact | Leslie H Sherman |
Correspondent | Leslie H Sherman IMPACT INSTRUMENTATION, INC. 27 FAIRFIELD PL. 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 | 2009-04-27 |
Decision Date | 2009-08-13 |
Summary: | summary |