SLEEP PAT 200 DEVICE— 510(k) K010156

Name: FDA 510(k) clearance K010156
Creator: U.S. Food and Drug Administration
Published: 2002-06-19

Substantially Equivalent

Itamar Medical (C.M.) 1997 , Ltd.

FDA 510(k) clearance K010156 for SLEEP PAT 200 DEVICE, Substantially Equivalent on 2002-06-19. Applicant: Itamar Medical (C.M.) 1997 , Ltd.. Device class: 2.

Clearance details

Applicant: Itamar Medical (C.M.) 1997 , Ltd.
Product code: Code MNR
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2001-01-16
Decision date: 2002-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hasbrouck Heights, NJ, US

Download summary PDF View on FDA.gov ↗

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