K110374 is an FDA 510(k) clearance for the MAX PULSE SYSTEM. This device is classified as a Plethysmograph, Photoelectric, Pneumatic Or Hydraulic (Class II - Special Controls, product code JOM).
Submitted by Medicore Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on June 13, 2011, 124 days after receiving the submission on February 9, 2011.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2780.
| 510(k) Number | K110374 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 09, 2011 |
| Decision Date | June 13, 2011 |
| Days to Decision | 124 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | JOM - Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2780 |