510(k) K761194
K761194 is an FDA 510(k) premarket notification submitted by Mckesson Corp. for the device "HLR QUICK-FIT HEART-LUNG RESUSCITATOR". The FDA issued a decision of Substantially Equivalent on December 9, 1976. The device falls under product code DRM (Compressor, Cardiac, External), a Class II device regulated under 21 CFR 870.5200. Mckesson Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 1976
- Date Received
- December 6, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Compressor, Cardiac, External
- Device Class
- Class II
- Regulation Number
- 870.5200
- Review Panel
- CV
- Submission Type