The following data is part of a premarket notification filed by Sharp Electronics Corp. with the FDA for Model Mt-50 Digital Memory Fever & Basal Thermomet.
| Device ID | K852194 |
| 510k Number | K852194 |
| Device Name: | MODEL MT-50 DIGITAL MEMORY FEVER & BASAL THERMOMET |
| Classification | Device, Fertility Diagnostic, Proceptive |
| Applicant | SHARP ELECTRONICS CORP. 10 SHARP PLAZA P.O. BOX 588 Paramus, NJ 07652 |
| Contact | Glen L Weinberg |
| Correspondent | Glen L Weinberg SHARP ELECTRONICS CORP. 10 SHARP PLAZA P.O. BOX 588 Paramus, NJ 07652 |
| Product Code | LHD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-20 |
| Decision Date | 1985-09-27 |