REMBRANDT SYSTEM— 510(k) K962865

Name: FDA 510(k) clearance K962865
Creator: U.S. Food and Drug Administration
Published: 1996-10-25

Substantially Equivalent - Subject to Tracking Reg.

Airsep Corp.

FDA 510(k) clearance K962865 for REMBRANDT SYSTEM, Substantially Equivalent - Subject to Tracking Reg. on 1996-10-25. Applicant: Airsep Corp.. Device class: 2.

Clearance details

Applicant: Airsep Corp.
Product code: Code FLS
Device class: Class 2
Regulation: 21 CFR 868.2377
Advisory panel: Anesthesiology
Date received: 1996-07-23
Decision date: 1996-10-25
Decision: Substantially Equivalent - Subject to Tracking Reg.
Clearance type: Traditional
Location: Buffalo, NY, US

Download summary PDF View on FDA.gov ↗

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