510(k) K011046
K011046 is an FDA 510(k) premarket notification submitted by Revivant Corp. for the device "AUTOPULSE, MODEL 100". The FDA issued a decision of Substantially Equivalent on October 25, 2001. 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
- October 25, 2001
- Date Received
- April 6, 2001
- 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