BAROguard— 510(k) K223874

Substantially Equivalent

Paragonix Technologies

FDA 510(k) clearance K223874 for BAROguard, Substantially Equivalent on 2023-08-15. Applicant: Paragonix Technologies.

Clearance details

Applicant: Paragonix Technologies
Product code: Code KDN
Advisory panel: Gastroenterology, Urology
Date received: 2022-12-23
Decision date: 2023-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Braintree, MA, US

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