The following data is part of a premarket notification filed by Impact Instrumentation, Inc. with the FDA for Impact Models 701, 702 And 703.
Device ID | K861272 |
510k Number | K861272 |
Device Name: | IMPACT MODELS 701, 702 AND 703 |
Classification | Ventilator, Emergency, Powered (resuscitator) |
Applicant | IMPACT INSTRUMENTATION, INC. P.O. BOX 412 Bogota, NJ 07603 |
Contact | Leslie H Sherman |
Correspondent | Leslie H Sherman IMPACT INSTRUMENTATION, INC. P.O. BOX 412 Bogota, NJ 07603 |
Product Code | BTL |
CFR Regulation Number | 868.5925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-04-04 |
Decision Date | 1986-05-20 |