FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THERMOMETER, SINGLE USE, STRIP, TEMPADOT
K Number: K771037
·
Decision Jun 27, 1977
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
13
Applicant Total
5
Review Days
17
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Basic Information
- Device Name
- THERMOMETER, SINGLE USE, STRIP, TEMPADOT
- K Number
- K771037
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.2900
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Info-Chem
- Date Received
- June 10, 1977
- Decision Date
- June 27, 1977
- 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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Other Clearances by Info-Chem
| K Number | Device Name | ||
|---|---|---|---|
| K810134 | KEEP-ACCOUNT SHARPS DISPOSAL SYSTEM | Feb 26, 1981 | Substantially Equivalent |
| K791574 | MODIFIED TEMPA-DOT THERMOMETER | Sep 12, 1979 | Substantially Equivalent |
| K772233 | THERMOMETER RECAL ADAPTER | Dec 20, 1977 | Substantially Equivalent |
| K771080 | STEAM STERILIZATION INDICATOR | Jul 14, 1977 | Substantially Equivalent |