Decision Date1977-10-18
Product CodeDSA
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
ELECTROCARDIOGRAPHIC CABLHS & LEAD WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Tronomed, Inc.. It received FDA 510(k) clearance on 1977-10-18 under 510(k) number K771645. 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 ELECTROCARDIOGRAPHIC CABLHS & LEAD WIRE?
ELECTROCARDIOGRAPHIC CABLHS & LEAD WIRE is a medical device that received FDA 510(k) clearance on 1977-10-18. The listed applicant is Tronomed, Inc.. The 510(k) number is K771645.
When did ELECTROCARDIOGRAPHIC CABLHS & LEAD WIRE receive FDA 510(k) clearance?
ELECTROCARDIOGRAPHIC CABLHS & LEAD WIRE received FDA 510(k) clearance on 1977-10-18, under 510(k) number K771645.
Who is the listed applicant for ELECTROCARDIOGRAPHIC CABLHS & LEAD WIRE?
The FDA 510(k) record lists Tronomed, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ELECTROCARDIOGRAPHIC CABLHS & LEAD WIRE?
The FDA product code for ELECTROCARDIOGRAPHIC CABLHS & LEAD WIRE is DSA.
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Official Source
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