DUAL SHOT ALPHA

FDA 510(k) clearance K071691 · decided 2007-12-19

Clearance details

K-number: K071691
Device name: DUAL SHOT ALPHA
Applicant: Nemoto Kyorindo Co., Ltd.
Decision: Substantially Equivalent
Date received: 2007-06-20
Decision date: 2007-12-19
Days to decision: 182 days
Clearance type: Special
Product code: DXT
Device class: 2
Regulation number: 870.1650
Medical specialty: Cardiovascular
Advisory committee: Cardiovascular
Location: Laguna Hills, CA, US
Third-party review: No
Expedited review: No

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Recalls involving this device

No recalls on record reference this clearance.