MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON— 510(k) K905575

Name: FDA 510(k) clearance K905575
Creator: U.S. Food and Drug Administration
Published: 1991-06-20

Substantially Equivalent

Edentec Corp.

FDA 510(k) clearance K905575 for MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON, Substantially Equivalent on 1991-06-20. Applicant: Edentec Corp.. Device class: 2.

Clearance details

Applicant: Edentec Corp.
Product code: Code BZQ
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 1990-12-12
Decision date: 1991-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

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