FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

SIDESTREAM DRUG NEBULIZER

K Number: K914152 · Decision May 5, 1992
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
507
Applicant Total
9
Review Days
232

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Basic Information

Device Name
SIDESTREAM DRUG NEBULIZER
K Number
K914152
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.5630
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Medic-Aid , Ltd.
Date Received
September 16, 1991
Decision Date
May 5, 1992
Product Code
CAF
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
CAF Nebulizer (Direct Patient Interface)

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (CAF), ordered by most recent decision date.

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Other Clearances by Medic-Aid , Ltd.

K Number Device Name
K991685 HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSOR
K981772 HALOLITE AAD SYSTEM
K971933 PORT-NEB
K934749 FREEWAY LITE NEBULIZER COMPRESSOR
K940888 SYSTEM 22 PAEDIATRIC MASK
K940887 SYSTEM 22 ADULT MASK
K933535 VENTSTREAM DRUG NEBULIZER
K924123 SIDESTREAM DISPOSABLE