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FDA 510(k)

ETV, ELECTRONIC VISION AID

K-Number: K884540 · 1989-01-19

ApplicantSevrain-Tech, Inc.
Decision Date1989-01-19
Product CodeHPE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ETV, ELECTRONIC VISION AID is the device name listed in this FDA 510(k) record. The listed applicant is Sevrain-Tech, Inc.. It received FDA 510(k) clearance on 1989-01-19 under 510(k) number K884540. The device is classified under product code HPE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ETV, ELECTRONIC VISION AID?

ETV, ELECTRONIC VISION AID is a medical device that received FDA 510(k) clearance on 1989-01-19. The listed applicant is Sevrain-Tech, Inc.. The 510(k) number is K884540.

When did ETV, ELECTRONIC VISION AID receive FDA 510(k) clearance?

ETV, ELECTRONIC VISION AID received FDA 510(k) clearance on 1989-01-19, under 510(k) number K884540.

Who is the listed applicant for ETV, ELECTRONIC VISION AID?

The FDA 510(k) record lists Sevrain-Tech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ETV, ELECTRONIC VISION AID?

The FDA product code for ETV, ELECTRONIC VISION AID is HPE.

Related Clinical Trials

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.

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Other records listing Sevrain-Tech, Inc. 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.

K883853ETA

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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