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FDA 510(k)

A-SCAN 100

K-Number: K024114 · 2003-01-10

ApplicantOphthalmic Technologies, Inc.
Decision Date2003-01-10
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

A-SCAN 100 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 2003-01-10 under 510(k) number K024114. 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 A-SCAN 100?

A-SCAN 100 is a medical device that received FDA 510(k) clearance on 2003-01-10. The listed applicant is Ophthalmic Technologies, Inc.. The 510(k) number is K024114.

When did A-SCAN 100 receive FDA 510(k) clearance?

A-SCAN 100 received FDA 510(k) clearance on 2003-01-10, under 510(k) number K024114.

Who is the listed applicant for A-SCAN 100?

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 A-SCAN 100?

The FDA product code for A-SCAN 100 is IYO.

Other records listing Ophthalmic Technologies, 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.

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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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