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510(k) K970428

Device
Rest X System
Applicant
RESTXSYS
510(k) number
K970428
Product code
FNM
Decision
Substantially Equivalent (SESE)
Decision date
1997-05-14
Date received
1997-02-04
Regulation
880.5550
Classification name
Mattress, Air Flotation, Alternating Pressure
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
YOAV GERSHONI
Address
19636 Club House Rd., Suite 120 Gaithersburg MD US 20879 20879

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FNM#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K973169PRESSURE GUARD SITE SELECT (A)Span-America Medical Systems, Inc.1998-02-20
K974319MIGHTY AIRWheelchairs of Kansas1998-01-22
K972022ZAK-2000Cardio Systems, Inc.1998-01-22
K974070PHYSIO/1000Physio Designs, Inc.1998-01-06
K972549SIMPULSEKinetic Concepts, Inc.1997-11-18
K970081SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEMCathay Consolidated, Inc.1997-11-07
K955243BARIAIRKinetic Concepts, Inc.1997-10-23
K970468KT AIR BEDKinetic Concepts, Inc.1997-09-05
K965207RID-DECUBE IISkin Care Management, Inc.1997-08-21
K972153ALTERNATING PRESSURE AIR FLOTATION MATTRESSDecubiti Concepts, Inc.1997-07-31
K971568REST MATTRESSRest Mattress1997-07-18
K954320MODIFIED PEDIKAIRKinetic Concepts, Inc.1997-07-18
K970362CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEMApex Metal, Inc.1997-05-16
K970350EQUI-PISE 1000 MRSAdvanced Air Support Consultancy, Inc.1997-04-22
K963674LUMEX AIRLumex, Inc.1997-01-10