The following data is part of a premarket notification filed by Mckesson Corp. with the FDA for Hlr Quick-fit Heart-lung Resuscitator.
Device ID | K761194 |
510k Number | K761194 |
Device Name: | HLR QUICK-FIT HEART-LUNG RESUSCITATOR |
Classification | Compressor, Cardiac, External |
Applicant | MCKESSON CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DRM |
CFR Regulation Number | 870.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-12-06 |
Decision Date | 1976-12-09 |