SpassageQ— 510(k) K230386

Substantially Equivalent

Spass, Inc.

FDA 510(k) clearance K230386 for SpassageQ, Substantially Equivalent on 2023-06-15. Applicant: Spass, Inc.. Device class: 2.

Clearance details

Applicant: Spass, Inc.
Product code: Code PLB
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2023-02-14
Decision date: 2023-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.