SCENAR (SCELAP, ENISAR, IPENS) CUTANEOUS ELECTRODE FAMILY
FDA 510(k) clearance K131513 · decided 2014-07-11
Clearance details
- K-number
- K131513
- Device name
- SCENAR (SCELAP, ENISAR, IPENS) CUTANEOUS ELECTRODE FAMILY
- Applicant
- Ritm Okb Zao
- Decision
- Substantially Equivalent
- Date received
- 2013-05-28
- Decision date
- 2014-07-11
- Days to decision
- 409 days
- Clearance type
- Traditional
- Product code
- GZJ
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Taganrog, RU
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.