The following data is part of a premarket notification filed by Gabriel Medical, Inc. with the FDA for Gabriel Medical Cls Thermal Recorder.
| Device ID | K901385 |
| 510k Number | K901385 |
| Device Name: | GABRIEL MEDICAL CLS THERMAL RECORDER |
| Classification | Recorder, Paper Chart |
| Applicant | GABRIEL MEDICAL, INC. 18662 MAC AUTHUR, SUITE 200 Irvine, CA 92715 |
| Contact | Harry Gabriel |
| Correspondent | Harry Gabriel GABRIEL MEDICAL, INC. 18662 MAC AUTHUR, SUITE 200 Irvine, CA 92715 |
| Product Code | DSF |
| CFR Regulation Number | 870.2810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-26 |
| Decision Date | 1990-05-09 |