FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MERCURY AND GLASS FEVER THERMOMETER
K Number: K911269
·
Decision May 15, 1991
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
32
Applicant Total
6
Review Days
54
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Basic Information
- Device Name
- MERCURY AND GLASS FEVER THERMOMETER
- K Number
- K911269
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2920
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Steridyne Corp.
- Date Received
- March 22, 1991
- Decision Date
- May 15, 1991
- Product Code
- FLK
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FLK | Thermometer, Clinical Mercury | FDA class 2 | General Hospital |
Similar 510(k) Clearances
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FDA Class 2
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AMG MED BRAND CLINICAL GLASS THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Steridyne Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K925352 | CLEAN CUFF BLOOD PRESSURE CUFF LINER | Jan 12, 1993 | Substantially Equivalent |
| K911843 | ZERO-G(TM) GEL/FOAM MATTRESS TOPPER | May 30, 1991 | Substantially Equivalent |
| K842120 | ZERO-G | Jun 8, 1984 | Substantially Equivalent |
| K821314 | FEVER METER | May 28, 1982 | Substantially Equivalent |
| K801458 | WINTER HEAD DRESSING | Jul 28, 1980 | Substantially Equivalent |