510(k) K102068
K102068 is an FDA 510(k) premarket notification submitted by Resuscitation International for the device "MINIATURIZE CHEST COMPRESSOR (MCC)". The FDA issued a decision of Substantially Equivalent on November 16, 2010. The device falls under product code DRM (Compressor, Cardiac, External), a Class II device regulated under 21 CFR 870.5200. Resuscitation International has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 16, 2010
- Date Received
- July 23, 2010
- 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