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

SPECTRUM DG-P7000 PEDIATRIC CRADLE

K Number: K933134 · Decision Oct 7, 1993
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
8
Applicant Total
9
Review Days
101

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Basic Information

Device Name
SPECTRUM DG-P7000 PEDIATRIC CRADLE
K Number
K933134
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
892.1830
Medical Specialty
Radiology
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Spectrum X-Ray Corp.
Date Received
June 28, 1993
Decision Date
October 7, 1993
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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K834494 SPECTRUM X-RAY CORP
K840463 DIGITAL CRADLE
K827450 SIMPLAMATIC III
K813561 SPECTRUM PEDIATRIC CARDLE TABLE
K791812 SPECTRUM EMERGENCY & TRAUMA TABLE SYSTEM
K791811 SPECTRUM AUTOMATIC CHEST UNIT MODEL C