FDA 510(k) FDA class 1 Substantially Equivalent 🇦🇺 Australia

YEESCOPE LARYNGOSCOPES

K Number: K140951 · Decision Nov 10, 2014
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
63
Applicant Total
1
Review Days
210

Basic Information

Device Name
YEESCOPE LARYNGOSCOPES
K Number
K140951
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
868.5540
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
YEESCOPE PTY. LTD.
Date Received
April 14, 2014
Decision Date
November 10, 2014
Product Code
CCW
Advisory Committee
Anesthesiology
Review Advisory Committee
AN
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
CCW Laryngoscope, Rigid

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