The following data is part of a premarket notification filed by Medicore Co., Ltd. with the FDA for Max Pulse System.
| Device ID | K110374 |
| 510k Number | K110374 |
| Device Name: | MAX PULSE SYSTEM |
| Classification | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| Applicant | MEDICORE CO., LTD. 3F, SAMWOO B/D, 339-2, JAMSIL DONG, SONGPA-GU Seoul, KR |
| 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 | 2011-02-09 |
| Decision Date | 2011-06-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40191237000036 | K110374 | 000 |