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510(k) K925576

Device
BURKE BARIATRIC TREATMENT SYSTEM II
Applicant
BURKE MOBILITY PRODUCTS
510(k) number
K925576
Product code
FNL  
Decision
Substantially Equivalent (SESE)
Decision date
1993-06-04
Date received
1992-11-03
Regulation
880.5100
Classification name
Bed, Ac-powered Adjustable Hospital
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
DUWAYNE E KRAMER
Address
P.O. Box 1064 Mission KS US 66222 66222

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FNL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K202964iBed Wireless with iBed MobileStryker Corporation2021-06-18
K103536IBED WIRELESS WITH IBED AWARENESSStryker Corporation2010-12-16
K982783VAIL 1000 ENCLOSED BEDVail Products, Inc.1998-10-05
K974296MODEL 720 SERIES FULL/SEMI ELECTRIC BED 1120 FULL ELECTRIC BEDInvacare Corp.1998-01-06
K974254BENEFIT B3--- SERIESM.C. Healthcare Products, Inc.1997-12-16
K972115VOLKER HOSPITAL BED, MODEL K960Volker Healthcare, Inc.1997-08-29
K971546SOMA 900 TRANSPORT BEDNova Technologies, Inc.1997-07-10
K963622VAIL 2000 ENCLOSED BEDVail Products, Inc.1997-05-07
K963589VAIL 3000 BED ENCLOSUREVail Products, Inc.1997-04-21
K962942TOTALCAREHill-Rom, Inc.1997-02-03
K963701SOMA SAFE ENCLOSURENova Technology Corp.1997-01-24
K964246NOVABED PATIENT TRANSFER SYSTEMNova Technology Corp.1997-01-22
K964515ACCLAIM SERIES QD6000,QD6001,QD6002 AND SERIES QD3000,QD3001, QD3002M.C. Healthcare Products, Inc.1996-12-31
K962250CARROLL HEALTHCARE DLX 2300-111 ELECTRIC BEDCarroll Healthcare, Inc.1996-10-21
K9627632000 MODULAR THIRTY-NINEEqui-Tron Mfg., Inc.1996-10-07

Legacy Summary#

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FDA Review#

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