SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE
FDA 510(k) clearance K101244 · decided 2010-11-18
Clearance details
- K-number
- K101244
- Device name
- SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE
- Applicant
- Truer Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-05-04
- Decision date
- 2010-11-18
- Days to decision
- 198 days
- Clearance type
- Traditional
- Product code
- FLL
- Device class
- 2
- Regulation number
- 880.2910
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Orange, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.