The following data is part of a premarket notification filed by Rg Ent., Inc. with the FDA for Geratherm Mercuiry Free Clinical Thermometer.
| Device ID | K960224 |
| 510k Number | K960224 |
| Device Name: | GERATHERM MERCUIRY FREE CLINICAL THERMOMETER |
| Classification | Thermometer, Clinical Mercury |
| Applicant | RG ENT., INC. 4217 HIGHLAND RD., #279 Waterford, MI 48328 |
| Contact | Daniel L. R Geczi |
| Correspondent | Daniel L. R Geczi RG ENT., INC. 4217 HIGHLAND RD., #279 Waterford, MI 48328 |
| Product Code | FLK |
| CFR Regulation Number | 880.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-17 |
| Decision Date | 1996-03-25 |