Decision Date2008-06-20
Product CodeDSA
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
PATIENT CABLE is the device name listed in this FDA 510(k) record. The listed applicant is Med-Dyne. It received FDA 510(k) clearance on 2008-06-20 under 510(k) number K080112. The device is classified under product code DSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PATIENT CABLE?
PATIENT CABLE is a medical device that received FDA 510(k) clearance on 2008-06-20. The listed applicant is Med-Dyne. The 510(k) number is K080112.
When did PATIENT CABLE receive FDA 510(k) clearance?
PATIENT CABLE received FDA 510(k) clearance on 2008-06-20, under 510(k) number K080112.
Who is the listed applicant for PATIENT CABLE?
The FDA 510(k) record lists Med-Dyne as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PATIENT CABLE?
The FDA product code for PATIENT CABLE is DSA.
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Official Source
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