FDA 510(k) Application Details - K042397

Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)

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510(K) Number K042397
Device Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant AIR TECHNIQUES, INC.
70 CANTIAGUE ROCK RD.
PO BOX 870
HICKSVILLE, NY 11802-0870 US
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Contact JOSEPH CAREY
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Regulation Number 892.1650

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Classification Product Code MQB
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Date Received 09/02/2004
Decision Date 10/05/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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