Decision Date2021-08-05
Product CodeJOH
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
TRACOE vario is the device name listed in this FDA 510(k) record. The listed applicant is Tracoe Medical GmbH. It received FDA 510(k) clearance on 2021-08-05 under 510(k) number K203362. The device is classified under product code JOH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TRACOE vario?
TRACOE vario is a medical device that received FDA 510(k) clearance on 2021-08-05. The listed applicant is Tracoe Medical GmbH. The 510(k) number is K203362.
When did TRACOE vario receive FDA 510(k) clearance?
TRACOE vario received FDA 510(k) clearance on 2021-08-05, under 510(k) number K203362.
Who is the listed applicant for TRACOE vario?
The FDA 510(k) record lists Tracoe Medical GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TRACOE vario?
The FDA product code for TRACOE vario is JOH.
Other records listing Tracoe Medical GmbH as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: JOH)
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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.