510(k) K141809
K141809 is an FDA 510(k) premarket notification submitted by Defibtech, LLC for the device "RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM". The FDA issued a decision of Substantially Equivalent on October 27, 2014. The device falls under product code DRM (Compressor, Cardiac, External), a Class II device regulated under 21 CFR 870.5200. Defibtech, LLC has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 27, 2014
- Date Received
- July 7, 2014
- 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