K183348 is an FDA 510(k) clearance for the Reusable Silicone Cover CPRmeter 2. 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 December 17, 2018, 14 days after receiving the submission on December 3, 2018.
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 | K183348 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 2018 |
| Decision Date | December 17, 2018 |
| Days to Decision | 14 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 |