AirKEE P900— 510(k) K232933

Substantially Equivalent

Healkee Medical Pte, Ltd.

FDA 510(k) clearance K232933 for AirKEE P900, Substantially Equivalent on 2024-05-16. Applicant: Healkee Medical Pte, Ltd.. Device class: 2.

Clearance details

Applicant: Healkee Medical Pte, Ltd.
Product code: Code FRA
Device class: Class 2
Regulation: 21 CFR 880.6500
Advisory panel: General Hospital
Date received: 2023-09-20
Decision date: 2024-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Singapore, SG

Download summary PDF View on FDA.gov ↗

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