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

SHOWER CHAIRS;BED/STRETCHER;LINEN & UTILITY CART

K Number: K895740 · Decision Feb 22, 1990
Classifications
1
FEI Numbers
105
Registration Numbers
105
Same Product Code
49
Applicant Total
8
Review Days
149

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Basic Information

Device Name
SHOWER CHAIRS;BED/STRETCHER;LINEN & UTILITY CART
K Number
K895740
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.6910
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Applicant
Lumex, Inc.
Date Received
September 26, 1989
Decision Date
February 22, 1990
Product Code
FPO
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
FPO Stretcher, Wheeled

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K Number Device Name
K963674 LUMEX AIR
K962123 AKROTECH 4000T KINETIC TURNING LOW AIR LOSS SYSTEM
K953675 ALTADYNE
K945175 MECHANICAL WHEELCHAIR 890.3850
K945257 577ES (ERGOSENSE)
K944574 LUMEX WHEELCHAIRS (SER. 1000, 3000, 4000, 5000, TILT-IN-SPACE, 6000, MRI)
K923977 AKROTECH 4000