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

SPECTRUM PEDIATRIC CARDLE TABLE

K Number: K813561 · Decision Jan 29, 1982
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
8
Applicant Total
9
Review Days
38

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Basic Information

Device Name
SPECTRUM PEDIATRIC CARDLE TABLE
K Number
K813561
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
892.1830
Medical Specialty
Radiology
Decision
Substantially Equivalent
Applicant
Spectrum X-Ray Corp.
Date Received
December 22, 1981
Decision Date
January 29, 1982
Product Code
KXH
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
KXH Cradle, Patient, Radiologic

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K870707 PENTAMAX 1 MODEL B TABLE SYSTEM
K834494 SPECTRUM X-RAY CORP
K840463 DIGITAL CRADLE
K827450 SIMPLAMATIC III
K791812 SPECTRUM EMERGENCY & TRAUMA TABLE SYSTEM
K791811 SPECTRUM AUTOMATIC CHEST UNIT MODEL C