MODIFICATION TO SUZANNE PORTABLE POLYSOMNOGRAPH SYSTEM— 510(k) K030611

Substantially Equivalent

Nellcor Puritan Bennett (Melville) , Ltd.

FDA 510(k) clearance K030611 for MODIFICATION TO SUZANNE PORTABLE POLYSOMNOGRAPH SYSTEM, Substantially Equivalent on 2003-03-24. Applicant: Nellcor Puritan Bennett (Melville) , Ltd.. Device class: 2.

Clearance details

Applicant
Nellcor Puritan Bennett (Melville) , Ltd.
Product code
Code MNR
Device class
Class 2
Regulation
21 CFR 868.2375
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Kanata, Ontario, CA
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