The following data is part of a premarket notification filed by Caf Medical Solutions Inc. with the FDA for Le-12ch.
| Device ID | K220362 |
| 510k Number | K220362 |
| Device Name: | LE-12CH |
| Classification | Electrocardiograph |
| Applicant | CAF Medical Solutions Inc. 17539 Roberts Road Hockley, TX 77477 |
| Contact | Oscar Arriaga Yamin |
| Correspondent | Juan Tezak Compliance 4 Devices 118 W Prive Cr. Delray Beach, FL 33445 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-08 |
| Decision Date | 2022-03-25 |