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FDA 510(k)

HF MODULE WITH TRANSDUCERS

K-Number: K031391 · 2003-06-20

ApplicantOphthalmic Technologies, Inc.
Decision Date2003-06-20
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HF MODULE WITH TRANSDUCERS is the device name listed in this FDA 510(k) record. The listed applicant is Ophthalmic Technologies, Inc.. It received FDA 510(k) clearance on 2003-06-20 under 510(k) number K031391. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HF MODULE WITH TRANSDUCERS?

HF MODULE WITH TRANSDUCERS is a medical device that received FDA 510(k) clearance on 2003-06-20. The listed applicant is Ophthalmic Technologies, Inc.. The 510(k) number is K031391.

When did HF MODULE WITH TRANSDUCERS receive FDA 510(k) clearance?

HF MODULE WITH TRANSDUCERS received FDA 510(k) clearance on 2003-06-20, under 510(k) number K031391.

Who is the listed applicant for HF MODULE WITH TRANSDUCERS?

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

What is the FDA product code for HF MODULE WITH TRANSDUCERS?

The FDA product code for HF MODULE WITH TRANSDUCERS is IYO.

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Other records listing Ophthalmic Technologies, Inc. as applicant

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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.

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