510(k) K151702
K151702 is an FDA 510(k) premarket notification submitted by Laerdal Medical AS for the device "Reusable Full Silicone Cover". The FDA issued a decision of Substantially Equivalent on August 13, 2015. The device falls under product code LIX (Aid, Cardiopulmonary Resuscitation), a Class II device regulated under 21 CFR 870.5210. Laerdal Medical AS has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 13, 2015
- Date Received
- June 24, 2015
- Clearance Type
- Special
- 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