The following data is part of a premarket notification filed by Sharp Electronics Corp. with the FDA for (mt-27) Thermometer And (m-10pc) Probe Covers.
| Device ID | K862333 |
| 510k Number | K862333 |
| Device Name: | (MT-27) THERMOMETER AND (M-10PC) PROBE COVERS |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | SHARP ELECTRONICS CORP. P.O.BOX 650 Mahwah, NJ 07430 |
| Contact | Weinberg, Pe |
| Correspondent | Weinberg, Pe SHARP ELECTRONICS CORP. P.O.BOX 650 Mahwah, NJ 07430 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-19 |
| Decision Date | 1986-07-08 |