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

MATTRESS, AIR FLOATATION, ALTERN. PRESS.

K Number: K803307 · Decision Jan 13, 1981
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
101
Applicant Total
6
Review Days
14

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Basic Information

Device Name
MATTRESS, AIR FLOATATION, ALTERN. PRESS.
K Number
K803307
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.5550
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Applicant
Intl. Medical Equipment Corp.
Date Received
December 30, 1980
Decision Date
January 13, 1981
Product Code
FNM
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
FNM Mattress, Air Flotation, Alternating Pressure

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K813104 POWER DRIVE WHEELCR