FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

FRIEDRICH ELECTRONIC AIR CLEANER

K Number: K944305 · Decision Aug 28, 1995
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
52
Applicant Total
1
Review Days
360

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Basic Information

Device Name
FRIEDRICH ELECTRONIC AIR CLEANER
K Number
K944305
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.5045
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Friedrich Air Conditioning Co., Inc.
Date Received
September 2, 1994
Decision Date
August 28, 1995
Product Code
FRF
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
FRF Cleaner, Air, Medical Recirculating

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