FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TEMPA-DOT CLINICAL THERMOMETER SHEATH
K Number: K881286
·
Decision Jun 8, 1988
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
13
Applicant Total
17
Review Days
75
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Basic Information
- Device Name
- TEMPA-DOT CLINICAL THERMOMETER SHEATH
- K Number
- K881286
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.2900
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Pymah Corp.
- Date Received
- March 25, 1988
- Decision Date
- June 8, 1988
- Product Code
- FQZ
- 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 |
|---|---|---|---|
| FQZ | Thermometer, Clinical Color Change | FDA class 1 | General Hospital |
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