SPIROSCOPE— 510(k) K905480

Substantially Equivalent

Grandcor Medical Systems

FDA 510(k) clearance K905480 for SPIROSCOPE, Substantially Equivalent on 1991-05-06. Applicant: Grandcor Medical Systems. Device class: 2.

Clearance details

Applicant
Grandcor Medical Systems
Product code
Code BZC
Device class
Class 2
Regulation
21 CFR 868.1880
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Dayton, OH, US
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