FDA 510(k) Application Details - K970234

Device Classification Name System, X-Ray, Mobile

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510(K) Number K970234
Device Name System, X-Ray, Mobile
Applicant PORTABLE POWER SYSTEMS, INC.
1940 TEE LN.
CASTLE ROCK, CO 80104 US
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Contact NORMAN A PREMO
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Regulation Number 892.1720

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Classification Product Code IZL
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Date Received 01/21/1997
Decision Date 05/02/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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