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MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K101703
510(k) Type
Special
Applicant
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/13/2010
Days to Decision
26 days
Submission Type
Summary

MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K101703
510(k) Type
Special
Applicant
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/13/2010
Days to Decision
26 days
Submission Type
Summary