FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

UV AIR STERILIGHT

K Number: K884579 · Decision Dec 12, 1988
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
35
Applicant Total
1
Review Days
39

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Basic Information

Device Name
UV AIR STERILIGHT
K Number
K884579
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.6500
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Applicant
Allseasons Environmental Control, Inc.
Date Received
November 3, 1988
Decision Date
December 12, 1988
Product Code
FRA
Advisory Committee
General Hospital
Review Advisory Committee
HO
Third Party
N

Classifications

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

Product Code Device Name
FRA Purifier, Air, Ultraviolet, Medical

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