The following data is part of a premarket notification filed by Caf Medical Solutions Inc. with the FDA for Patient Monitor, Models Lm-8, Lm-10, Lm-12 And Lm-15.
| Device ID | K221879 |
| 510k Number | K221879 |
| Device Name: | Patient Monitor, Models LM-8, LM-10, LM-12 And LM-15 |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | CAF Medical Solutions Inc. 17539 Roberts Road Hockley, TX 77477 |
| Contact | Oscar Arriaga Yamin |
| Correspondent | Juan Tezak Compliance 4 Device 118 W Prive Cr. Delray Beach, FL 33445 |
| Product Code | MHX |
| Subsequent Product Code | BZK |
| Subsequent Product Code | BZQ |
| Subsequent Product Code | CBQ |
| Subsequent Product Code | CBR |
| Subsequent Product Code | CBS |
| Subsequent Product Code | CCK |
| Subsequent Product Code | CCL |
| Subsequent Product Code | DPS |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRG |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DSB |
| Subsequent Product Code | DSK |
| Subsequent Product Code | DST |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| Subsequent Product Code | MLD |
| Subsequent Product Code | NHO |
| Subsequent Product Code | NHP |
| Subsequent Product Code | &nb |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-28 |
| Decision Date | 2022-08-10 |