Clearance Summary
HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100 received FDA 510(k) clearance under submission number K062119, sponsored by Medical Products Mfg., LLC. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2006-09-22.
- Submission: K062119
- Applicant / Sponsor: Medical Products Mfg., LLC
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5200
- Decision date: 2006-09-22
Classification & Regulation
This clearance is catalogued under FDA product code DRM and 21 CFR 870.5200, within the Cardiovascular review panel as a Class II device.