The following data is part of a premarket notification filed by Impact Instrumentation, Inc. with the FDA for Impact Model 753.
Device ID | K931473 |
510k Number | K931473 |
Device Name: | IMPACT MODEL 753 |
Classification | Ventilator, Emergency, Powered (resuscitator) |
Applicant | IMPACT INSTRUMENTATION, INC. P.O. BOX 508 West Caldwell, NJ 07006 |
Contact | Leslie Sherman |
Correspondent | Leslie Sherman IMPACT INSTRUMENTATION, INC. P.O. BOX 508 West Caldwell, NJ 07006 |
Product Code | BTL |
CFR Regulation Number | 868.5925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-24 |
Decision Date | 1994-12-30 |