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510(k) K884493

Device
HEAD HOLDING DEVICE/SLEEP APNEA
Applicant
X-RAY SYSTEMS
510(k) number
K884493
Product code
IWY  
Decision
Substantially Equivalent (SESE)
Decision date
1989-01-12
Date received
1988-10-26
Regulation
892.1920
Classification name
Holder, Head, Radiographic
Medical specialty
Radiology
Review panel
Radiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
RICHARD C DRUMB
Address
33061 Groesbeck Hwy. Fraser MI US 48026 48026

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IWY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K925705ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEMDenar Corp.1992-12-28
K884847MTD HEDRESTComposites Horizons, Inc.1989-01-09
K864527DUOCEPHGary E. Hall, Dds1987-01-07
K850197KELLER CEPHALOMETRIC DEVICEGary D. Keller1985-03-22
K844549HEAD-SPINE STABILIZER HSS-1Imaging Accessories, Inc.1985-03-01
K843340PORTA-STATPorta-Stat, Inc.1984-11-27
K834559DELUXE WALL-MOUNTED CEPHALOMETERKnochen Dental Laboratory1984-02-21
K802140LEKSELL STEREOTACTIC SYSTEMDowns Surgical , Ltd.1981-02-05
K772313X-RAY CO-ORDINATORRinn Corp.1978-01-30

Legacy Summary#

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FDA Review#

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