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510(k) K954162

Device
ERGOSEAT SYSTEM
Applicant
ERGO-AIR, INC.
510(k) number
K954162
Product code
MOC  
Decision
Substantially Equivalent (SESE)
Decision date
1995-10-30
Date received
1995-09-05
Regulation
890.5170
Classification name
Cushion, Flotation, Therapeutic
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
MARGARET N WAINWRIGHT
Address
24 Watson St. Marblehead MA US 01945 01945

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MOC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K063175IPUP 200 (INTELLIGENT PRESSURE ULCER PREVENTION)Medical Technology Systems, Inc.2008-03-14

Legacy Summary#

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FDA Review#

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