AVITA AGIL IT 101 INSTANT DIGITAL THERMOMETER
FDA 510(k) clearance K012136 · decided 2001-09-10
Clearance details
- K-number
- K012136
- Device name
- AVITA AGIL IT 101 INSTANT DIGITAL THERMOMETER
- Applicant
- Avita Corporation
- Decision
- Substantially Equivalent
- Date received
- 2001-07-09
- Decision date
- 2001-09-10
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- FLL
- Device class
- 2
- Regulation number
- 880.2910
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Flaggstaff, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.