K073323 is an FDA 510(k) clearance for the SA-3000P. This device is classified as a Plethysmograph, Photoelectric, Pneumatic Or Hydraulic (Class II - Special Controls, product code JOM).
Submitted by Medicore Co., Ltd. (Gangnam-Gu, Seoul, KR). The FDA issued a Cleared decision on November 29, 2007, 2 days after receiving the submission on November 27, 2007.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2780.
| 510(k) Number | K073323 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 27, 2007 |
| Decision Date | November 29, 2007 |
| Days to Decision | 2 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 |