510(k) K852194

MODEL MT-50 DIGITAL MEMORY FEVER & BASAL THERMOMET by Sharp Electronics Corp. — Product Code LHD

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