FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AVITA AGIL IT 101 INSTANT DIGITAL THERMOMETER
K Number: K012136
·
Decision Sep 10, 2001
Classifications
1
FEI Numbers
488
Registration Numbers
488
Same Product Code
797
Applicant Total
27
Review Days
63
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Basic Information
- Device Name
- AVITA AGIL IT 101 INSTANT DIGITAL THERMOMETER
- K Number
- K012136
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2910
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Avita Corporation
- Date Received
- July 9, 2001
- Decision Date
- September 10, 2001
- 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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| K200346 | Wrist Type Blood Pressure Monitor | Dec 17, 2020 | Substantially Equivalent |
| K180155 | Arm Type Blood Pressure Monitor | Aug 3, 2018 | Substantially Equivalent |
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