FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

#400 BROOK AIRWAY & #900 PROFESSIONAL BROOK AIRWAY

K Number: K883593 · Decision Sep 30, 1988
Classifications
1
FEI Numbers
229
Registration Numbers
229
Same Product Code
56
Applicant Total
7
Review Days
38

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Basic Information

Device Name
#400 BROOK AIRWAY & #900 PROFESSIONAL BROOK AIRWAY
K Number
K883593
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
868.5110
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Ecolab, Inc.
Date Received
August 23, 1988
Decision Date
September 30, 1988
Product Code
CAE
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
CAE Airway, Oropharyngeal, Anesthesiology

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K150190 IntraTemp Solution Warmer
K142173 NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE
K142080 NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED