The following data is part of a premarket notification filed by Meridian Co., Ltd. with the FDA for Mcpulse.
| Device ID | K023238 |
| 510k Number | K023238 |
| Device Name: | MCPULSE |
| Classification | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| Applicant | MERIDIAN CO., LTD. PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm MERIDIAN CO., LTD. PO BOX 7007 Deerfield, IL 60015 |
| Product Code | JOM |
| CFR Regulation Number | 870.2780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-27 |
| Decision Date | 2003-02-19 |
| Summary: | summary |