Decision Date1982-10-04
Product CodeDXY
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
ENERTRAX MODEL 7100E is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1982-10-04 under 510(k) number K822297. The device is classified under product code DXY. It was reviewed by the CV advisory panel. Product code DXY falls under the category of Clinical Chemistry, which covers reagents and instruments for chemical analysis of clinical samples. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ENERTRAX MODEL 7100E?
ENERTRAX MODEL 7100E is a medical device that received FDA 510(k) clearance on 1982-10-04. The listed applicant is Medtronic Vascular. The 510(k) number is K822297.
When did ENERTRAX MODEL 7100E receive FDA 510(k) clearance?
ENERTRAX MODEL 7100E received FDA 510(k) clearance on 1982-10-04, under 510(k) number K822297.
Who is the listed applicant for ENERTRAX MODEL 7100E?
The FDA 510(k) record lists Medtronic Vascular as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ENERTRAX MODEL 7100E?
The FDA product code for ENERTRAX MODEL 7100E is DXY. This falls under the Clinical Chemistry category.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.