FDA 510(k) Applications for Medical Device Product Code "KZM"
(Device, Muscle Monitoring)

FDA 510(k) Number Applicant Device Name Decision Date
K003176 BIO-RESEARCH ASSOCIATES, INC. BIOEMG II AND BIOJVA 01/04/2001
K082927 BIO-RESEARCH ASSOCIATES, INC. BIOEMG III 02/06/2009
K981563 BIO-RESEARCH ASSOCIATES, INC. BIOPAK MEASUREMENT SYSTEM 09/15/1998
K130158 BIO-RESEARCH ASSOCIATES, INC. M-SCAN 07/25/2013
K161716 BTS S.P.A. TEETHAN 2.0 12/21/2016
K113677 MEDOTECH A/S GRINDCARE MEASURE 04/05/2012
K003287 MYOTRONICS-NOROMED, INC. MODEL K7 EVALUATION DEVICE 11/06/2000
K992694 MYOTRONICS-NOROMED, INC. MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I 09/10/1999
K043373 NEUROMUSCULAR TECHNOLOGIES, INC. DOLOTENS DENTAL TM 1 09/02/2005
K030869 S.L.P. LTD. BITESTRIP 05/14/2004


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