510(k) K024215
K024215 is an FDA 510(k) premarket notification submitted by Enertron Engineering Co. for the device "ENERTRON CPR JACK". The FDA issued a decision of Substantially Equivalent on May 14, 2004. The device falls under product code DRM (Compressor, Cardiac, External), a Class II device regulated under 21 CFR 870.5200.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 14, 2004
- Date Received
- December 20, 2002
- 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