STIM PROBE
FDA 510(k) clearance K133348 · decided 2014-11-21
Clearance details
- K-number
- K133348
- Device name
- STIM PROBE
- Applicant
- Spes Medica Srl
- Decision
- Substantially Equivalent
- Date received
- 2013-10-30
- Decision date
- 2014-11-21
- Days to decision
- 387 days
- Clearance type
- Traditional
- Product code
- ETN
- Device class
- 2
- Regulation number
- 874.1820
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Battipaglia, IT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.