The following data is part of a premarket notification filed by Medicore Co., Ltd. with the FDA for Sa-3000p.
| Device ID | K073323 |
| 510k Number | K073323 |
| Device Name: | SA-3000P |
| Classification | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| Applicant | MEDICORE CO., LTD. 4F LUNA B/D 72-3 CHUNGDAM-DONG Gangnam-gu, Seoul, KR 92673 |
| Contact | Yoo Byung-kuk |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | JOM |
| CFR Regulation Number | 870.2780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-11-27 |
| Decision Date | 2007-11-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10191237000011 | K073323 | 000 |