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 | Device Class | Medical Specialty |
|---|---|---|---|
| LHD | Device, Fertility Diagnostic, Proceptive | FDA unclassified | Unknown |
Similar 510(k) Clearances
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LADY COMP USA
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FDA Unclassified
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MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921
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FDA Unclassified
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PETIT SOPHIA
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Sharp Electronics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K880715 | (MB-650) BLOOD PRESSURE MONITOR | May 9, 1988 | Substantially Equivalent |
| K875093 | NEW MODEL MB-550 BLOOD PRESSURE MONITOR | Feb 5, 1988 | Substantially Equivalent |
| K863672 | MODEL (MB-700) BLOOD PRESSURE MONITOR | Nov 18, 1986 | Substantially Equivalent |
| K861375 | MODEL MB-500 & MB-600 BLOOD PRESSURE MONITORS | Aug 6, 1986 | Substantially Equivalent |
| K862333 | (MT-27) THERMOMETER AND (M-10PC) PROBE COVERS | Jul 8, 1986 | Substantially Equivalent |
| K851664 | MODEL MB-309H, SHARP DIGITAL BLOOD PRESSURE MONITO | Jul 24, 1985 | Substantially Equivalent |
| K850830 | SHARP DIGITAL BP MONITOR MB-371H | Jun 13, 1985 | Substantially Equivalent |
| K842200 | MD308H DIGITAL/MB351H AUTO-BP MONITOR | Oct 24, 1984 | Substantially Equivalent |
| K842199 | ELEC. DIGITAL THERMOMETER MT-20 & 30 | Jul 18, 1984 | Substantially Equivalent |