510(k) K010526
K010526 is an FDA 510(k) premarket notification submitted by Elcare Innovations, Inc. for the device "MODIFICATION TO THE GRIP". The FDA issued a decision of Substantially Equivalent on December 13, 2001. The device falls under product code LIX (Aid, Cardiopulmonary Resuscitation), a Class II device regulated under 21 CFR 870.5210.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 13, 2001
- Date Received
- February 22, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Aid, Cardiopulmonary Resuscitation
- Device Class
- Class II
- Regulation Number
- 870.5210
- Review Panel
- CV
- Submission Type
CPR Aid device WITH feedback (visual, audio or both) on one or more CPR parameters (e.g., rate, depth, ventilation ratio, etc.), and contains software. Provides real-time feedback on CPR performance. Feedback can be audio, visual or both. Device contains software