FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

DELUXE WALL-MOUNTED CEPHALOMETER

K Number: K834559 · Decision Feb 21, 1984
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
9
Applicant Total
2
Review Days
55

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Basic Information

Device Name
DELUXE WALL-MOUNTED CEPHALOMETER
K Number
K834559
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
892.1920
Medical Specialty
Radiology
Decision
Substantially Equivalent
Applicant
Knochen Dental Laboratory
Date Received
December 28, 1983
Decision Date
February 21, 1984
Product Code
IWY
Advisory Committee
Radiology
Review Advisory Committee
RA
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
IWY Holder, Head, Radiographic

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Other Clearances by Knochen Dental Laboratory

K Number Device Name
K834606 X-RAY COLLIMATOR X-CJD