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510(k) K953675

Device
ALTADYNE
Applicant
LUMEX, INC.
510(k) number
K953675
Product code
FNM  
Decision
Substantially Equivalent (SESE)
Decision date
1995-09-28
Date received
1995-08-07
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
Summary
Third party reviewed
No

Applicant Contact#

Contact
JAMES TERRACCIANO
Address
100 Spence St. Bay Shore NY US 11706 11706

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
K970428REST X SYSTEMRestxsys1997-05-14
K970350EQUI-PISE 1000 MRSAdvanced Air Support Consultancy, Inc.1997-04-22

Legacy Summary#

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FDA Review#

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