The following data is part of a premarket notification filed by Healthcheck Corp. with the FDA for Healthcheck Digital Thermometer Model 1 Th-2.
| Device ID | K851379 |
| 510k Number | K851379 |
| Device Name: | HEALTHCHECK DIGITAL THERMOMETER MODEL 1 TH-2 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | HEALTHCHECK CORP. 150 SANDBANK RD. Cheshire, CT 06410 |
| Contact | David R Balzer |
| Correspondent | David R Balzer HEALTHCHECK CORP. 150 SANDBANK RD. Cheshire, CT 06410 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-08 |
| Decision Date | 1985-04-12 |