I RUNE (I-200L)
FDA 510(k) clearance K122410 · decided 2013-11-12
Clearance details
- K-number
- K122410
- Device name
- I RUNE (I-200L)
- Applicant
- Medirune Co, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2012-08-08
- Decision date
- 2013-11-12
- Days to decision
- 461 days
- Clearance type
- Traditional
- Product code
- NUH
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Gangnam-Gu, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.