MICROLIFE DIGITAL ELECTRONIC THERMOMETER, MODEL MT16K1
FDA 510(k) clearance K091589 · decided 2009-06-10
Clearance details
- K-number
- K091589
- Device name
- MICROLIFE DIGITAL ELECTRONIC THERMOMETER, MODEL MT16K1
- Applicant
- Microlife Intellectual Property GmbH
- Decision
- Substantially Equivalent
- Date received
- 2009-06-02
- Decision date
- 2009-06-10
- Days to decision
- 8 days
- Clearance type
- Special
- 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
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.