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AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015

Page Type
Cleared 510(K)
510(k) Number
K093622
510(k) Type
Traditional
Applicant
ENCISION, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/20/2010
Days to Decision
270 days
Submission Type
Summary

AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015

Page Type
Cleared 510(K)
510(k) Number
K093622
510(k) Type
Traditional
Applicant
ENCISION, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/20/2010
Days to Decision
270 days
Submission Type
Summary