SONIC SHOT GX
FDA 510(k) clearance K091734 · decided 2010-05-21
Clearance details
- K-number
- K091734
- Device name
- SONIC SHOT GX
- Applicant
- Nemoto Kyorindo Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2009-06-11
- Decision date
- 2010-05-21
- Days to decision
- 344 days
- Clearance type
- Traditional
- Product code
- IZQ
- Device class
- 2
- Regulation number
- 870.1650
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Kawaguchi-Shi, Saitama, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.