The following data is part of a premarket notification filed by Healthcheck Corp. with the FDA for Healthcheck Therm-strip.
| Device ID | K863181 |
| 510k Number | K863181 |
| Device Name: | HEALTHCHECK THERM-STRIP |
| Classification | Thermometer, Clinical Color Change |
| Applicant | HEALTHCHECK CORP. 150 SANDBANK RD. Cheshire, CT 06410 |
| Contact | Balzer, Jr. |
| Correspondent | Balzer, Jr. HEALTHCHECK CORP. 150 SANDBANK RD. Cheshire, CT 06410 |
| Product Code | FQZ |
| CFR Regulation Number | 880.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-19 |
| Decision Date | 1986-09-11 |