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

CONSUMMATE AIR THERAPY BED

K Number: K890426 · Decision Apr 5, 1989
Classifications
1
FEI Numbers
228
Registration Numbers
228
Same Product Code
69
Applicant Total
13
Review Days
69

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Basic Information

Device Name
CONSUMMATE AIR THERAPY BED
K Number
K890426
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.5100
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Applicant
Health Products, Inc.
Date Received
January 26, 1989
Decision Date
April 5, 1989
Product Code
FNL
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
FNL Bed, Ac-Powered Adjustable Hospital

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Other Clearances by Health Products, Inc.

K Number Device Name
K912866 PEAK EXPIRATORY FLOW METER
K912943 THRESHOLD 2X INSPIRATORY MUSCLE TRAINER
K911807 METERED DOSE INHALER (MDI) SPACER
K902292 MODIFIED ASSESS(R) PEAK FLOW METER
K896953 MODIFIED ASSESS(R) PEAK FLOW METER
K894353 ORTHODERM CONVERTIBLE
K874801 ORTHODERM THERAPY BED
K871742 MODIFIED USE OF PLEX INSPIRATORY MUSCLE TRAINER
K870514 THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER
K864719 PFLEX EM(TM) (EXERCISE MONITOR)
Search all 13 clearances from Health Products, Inc. →