ASAHI FUBUKI 043 / ASAHI FUBUKI
FDA 510(k) clearance K141981 · decided 2015-03-09
Clearance details
- K-number
- K141981
- Device name
- ASAHI FUBUKI 043 / ASAHI FUBUKI
- Applicant
- Asahi Intecc Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2014-07-21
- Decision date
- 2015-03-09
- Days to decision
- 231 days
- Clearance type
- Traditional
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Baltimore, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.