SLEEPWIZARD— 510(k) K964494

Substantially Equivalent

Nellcor Puritan Bennett, Inc.

FDA 510(k) clearance K964494 for SLEEPWIZARD, Substantially Equivalent on 1997-02-04. Applicant: Nellcor Puritan Bennett, Inc.. Device class: 2.

Clearance details

Applicant: Nellcor Puritan Bennett, Inc.
Product code: Code MNR
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 1996-11-08
Decision date: 1997-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

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