AMPLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL E101
FDA 510(k) clearance K042906 · decided 2004-11-19
Clearance details
- K-number
- K042906
- Device name
- AMPLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL E101
- Applicant
- Amplife Corporation
- Decision
- Substantially Equivalent
- Date received
- 2004-10-21
- Decision date
- 2004-11-19
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- FLL
- Device class
- 2
- Regulation number
- 880.2910
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Great Neck, NY, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.