FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
EAR THERMOMETER, MODEL WL-320X
K Number: K042631
·
Decision Dec 22, 2004
Classifications
1
FEI Numbers
518
Registration Numbers
518
Same Product Code
795
Applicant Total
2
Review Days
86
Basic Information
- Device Name
- EAR THERMOMETER, MODEL WL-320X
- K Number
- K042631
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2910
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- INNOVATECH, INC
- Date Received
- September 27, 2004
- Decision Date
- December 22, 2004
- Product Code
- FLL
- 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 |
|---|---|---|---|
| FLL | Continuous Measurement Thermometer | FDA class 2 | General Hospital |
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Other Clearances by INNOVATECH, INC
| K Number | Device Name | ||
|---|---|---|---|
| K023500 | DIGITAL CLINICAL THERMOMETER, MODEL BABY TEMP/WL-3305 AND BABY TEMP (+) /WL-3306 | Dec 13, 2002 | Substantially Equivalent |