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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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510(K)
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Decision
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cardionow cardiology wide area archive and retrieval system CARDIONOW, INC. k020449 05/10/2002
validate chem 8 calibration verification test set; model 108 MAINE STANDARDS CO. k020450 03/21/2002
comfort wheelchairs COMFORT ORTHOPEDIC CO. LTD. k020451 03/14/2002
high silver conventional AB ARDENT k020452 05/07/2002
palomar estelux pulsed light system and palomar coolroller PALOMAR MEDICAL TECHNOLOGIES, INC. k020453 05/10/2002
chemistry calibrator JAS Diagnostics, Inc. k020454 04/08/2002
tissuemend soft tissue repair matrix TEI BIOSCIENCES INC. k020455 04/03/2002
easi 12 lead algorithm PHILIPS MEDICAL SYSTEMS k020456 07/09/2002
axiamed trans-sacral spinal access device AXIAMED, INC. k020457 09/26/2002
sanidad thermal far-infrared wave lamp, model ap-2018 ROLOR ELECTRONICS CORP. k020462 09/16/2002

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