K151702 is an FDA 510(k) clearance for the Reusable Full Silicone Cover. This device is classified as a Aid, Cardiopulmonary Resuscitation (Class II - Special Controls, product code LIX).
Submitted by Laerdal Medical AS (Stavanger, NO). The FDA issued a Cleared decision on August 13, 2015, 50 days after receiving the submission on June 24, 2015.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5210. 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.
| 510(k) Number | K151702 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 2015 |
| Decision Date | August 13, 2015 |
| Days to Decision | 50 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | LIX - Aid, Cardiopulmonary Resuscitation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5210 |
| Definition | 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 |