FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GEON RAPID DIGITAL THERMOMETER MODEL: MT-B117, MT-B127, MT-B130, MT-B132FA
K Number: K100563
·
Decision Jun 2, 2010
Classifications
1
FEI Numbers
518
Registration Numbers
518
Same Product Code
795
Applicant Total
1
Review Days
93
Basic Information
- Device Name
- GEON RAPID DIGITAL THERMOMETER MODEL: MT-B117, MT-B127, MT-B130, MT-B132FA
- K Number
- K100563
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2910
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- GEON CORPORATION
- Date Received
- March 1, 2010
- Decision Date
- June 2, 2010
- 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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