CuffGuard— 510(k) K243562

Substantially Equivalent

Idmed

FDA 510(k) clearance K243562 for CuffGuard, Substantially Equivalent on 2025-08-12. Applicant: Idmed. Device class: 2.

Clearance details

Applicant: Idmed
Product code: Code BSK
Device class: Class 2
Regulation: 21 CFR 868.5750
Advisory panel: Anesthesiology
Date received: 2024-11-18
Decision date: 2025-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marseille, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code BSK

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K221477 — AG100s2022-12-29
K202874 — Puritan Bennett Cuff Pressure Manager2021-01-09

More clearances from Idmed

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K172690 — ToFscan2018-05-31

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