510(k) K153628
K153628 is an FDA 510(k) premarket notification submitted by Resuscitation International, LLC for the device "ROSC-U Mini Chest Compressor (RMCC)". The FDA issued a decision of Substantially Equivalent on January 30, 2016. The device falls under product code DRM (Compressor, Cardiac, External), a Class II device regulated under 21 CFR 870.5200. Resuscitation International, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 2016
- Date Received
- December 18, 2015
- 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