The following data is part of a premarket notification filed by Gabriel Ent. with the FDA for Gabriel Digitrend.
| Device ID | K822795 |
| 510k Number | K822795 |
| Device Name: | GABRIEL DIGITREND |
| Classification | Device, Temperature Measurement, Direct Contact, Powered |
| Applicant | GABRIEL ENT. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HCS |
| CFR Regulation Number | 882.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-16 |
| Decision Date | 1982-10-08 |