510(k) K032852
K032852 is an FDA 510(k) premarket notification submitted by Revivant Corp. for the device "MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100". The FDA issued a decision of Substantially Equivalent on November 12, 2003. The device falls under product code DRM (Compressor, Cardiac, External), a Class II device regulated under 21 CFR 870.5200. Revivant Corp. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 12, 2003
- Date Received
- September 12, 2003
- Clearance Type
- Special
- 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