The following data is part of a premarket notification filed by Pymah Corp. with the FDA for Tempa-dot Clinical Thermometer Sheath.
| Device ID | K881286 |
| 510k Number | K881286 |
| Device Name: | TEMPA-DOT CLINICAL THERMOMETER SHEATH |
| Classification | Thermometer, Clinical Color Change |
| Applicant | PYMAH CORP. 89 ROUTE 206 PO BOX 1114 Somerville, NJ 08876 |
| Contact | Thomas Thackston |
| Correspondent | Thomas Thackston PYMAH CORP. 89 ROUTE 206 PO BOX 1114 Somerville, NJ 08876 |
| Product Code | FQZ |
| CFR Regulation Number | 880.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-25 |
| Decision Date | 1988-06-08 |