Clearance Summary
LIFE PULSE RESUSCITATION TIMER received FDA 510(k) clearance under submission number K932867, sponsored by Green Field Medical Sourcing, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1994-07-25.
- Submission: K932867
- Applicant / Sponsor: Green Field Medical Sourcing, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.5210
- Decision date: 1994-07-25
Classification & Regulation
This clearance is catalogued under FDA product code PMK and 21 CFR 870.5210, within the Cardiovascular review panel as a Class I device.