FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

MODEL MT-50 DIGITAL MEMORY FEVER & BASAL THERMOMET

K Number: K852194 · Decision Sep 27, 1985
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
23
Applicant Total
10
Review Days
130

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Basic Information

Device Name
MODEL MT-50 DIGITAL MEMORY FEVER & BASAL THERMOMET
K Number
K852194
Device Class
FDA unclassified
Clearance Type
Traditional
Medical Specialty
Unknown
Decision
Substantially Equivalent
Applicant
Sharp Electronics Corp.
Date Received
May 20, 1985
Decision Date
September 27, 1985
Product Code
LHD
Advisory Committee
Unknown
Review Advisory Committee
OB
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
LHD Device, Fertility Diagnostic, Proceptive

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Other Clearances by Sharp Electronics Corp.

K Number Device Name
K880715 (MB-650) BLOOD PRESSURE MONITOR
K875093 NEW MODEL MB-550 BLOOD PRESSURE MONITOR
K863672 MODEL (MB-700) BLOOD PRESSURE MONITOR
K861375 MODEL MB-500 & MB-600 BLOOD PRESSURE MONITORS
K862333 (MT-27) THERMOMETER AND (M-10PC) PROBE COVERS
K851664 MODEL MB-309H, SHARP DIGITAL BLOOD PRESSURE MONITO
K850830 SHARP DIGITAL BP MONITOR MB-371H
K842200 MD308H DIGITAL/MB351H AUTO-BP MONITOR
K842199 ELEC. DIGITAL THERMOMETER MT-20 & 30