UniPulse— 510(k) K182905

Substantially Equivalent

Seaward Group

FDA 510(k) clearance K182905 for UniPulse, Substantially Equivalent on 2018-12-14. Applicant: Seaward Group.

Clearance details

Applicant: Seaward Group
Product code: Code DRL
Advisory panel: Cardiovascular
Date received: 2018-10-16
Decision date: 2018-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Peterlee, GB

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