510(k) K852194
K852194 is an FDA 510(k) premarket notification submitted by Sharp Electronics Corp. for the device "MODEL MT-50 DIGITAL MEMORY FEVER & BASAL THERMOMET". The FDA issued a decision of Substantially Equivalent on September 27, 1985. The device falls under product code LHD (Device, Fertility Diagnostic, Proceptive), a Class U device. Sharp Electronics Corp. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 1985
- Date Received
- May 20, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Fertility Diagnostic, Proceptive
- Device Class
- Class U
- Regulation Number
- Review Panel
- OB
- Submission Type