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FDA 510(k)

EPIX VT

K-Number: K970203 · 1997-04-14

ApplicantEmpi
Decision Date1997-04-14
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EPIX VT is the device name listed in this FDA 510(k) record. The listed applicant is Empi. It received FDA 510(k) clearance on 1997-04-14 under 510(k) number K970203. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPIX VT?

EPIX VT is a medical device that received FDA 510(k) clearance on 1997-04-14. The listed applicant is Empi. The 510(k) number is K970203.

When did EPIX VT receive FDA 510(k) clearance?

EPIX VT received FDA 510(k) clearance on 1997-04-14, under 510(k) number K970203.

Who is the listed applicant for EPIX VT?

The FDA 510(k) record lists Empi as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EPIX VT?

The FDA product code for EPIX VT is GZJ.

Other records listing Empi 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.

View all 60 devices →

Related Devices (Code: GZJ)

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.

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.

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