FDA 510(k)

MEGATRON OPHTHALMIC SURGICAL SYSTEM

K-Number: K961658 · 1996-07-23

ApplicantIntl. Ophthalmic Industries Corp.

Decision Date1996-07-23

Product CodeHQC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

MEGATRON OPHTHALMIC SURGICAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Ophthalmic Industries Corp.. It received FDA 510(k) clearance on 1996-07-23 under 510(k) number K961658. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEGATRON OPHTHALMIC SURGICAL SYSTEM?

MEGATRON OPHTHALMIC SURGICAL SYSTEM is a medical device that received FDA 510(k) clearance on 1996-07-23. The listed applicant is Intl. Ophthalmic Industries Corp.. The 510(k) number is K961658.

When did MEGATRON OPHTHALMIC SURGICAL SYSTEM receive FDA 510(k) clearance?

MEGATRON OPHTHALMIC SURGICAL SYSTEM received FDA 510(k) clearance on 1996-07-23, under 510(k) number K961658.

Who is the listed applicant for MEGATRON OPHTHALMIC SURGICAL SYSTEM?

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

What is the FDA product code for MEGATRON OPHTHALMIC SURGICAL SYSTEM?

The FDA product code for MEGATRON OPHTHALMIC SURGICAL SYSTEM is HQC.

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Other records listing Intl. Ophthalmic Industries Corp. as applicant

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Related Devices (Code: HQC)

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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.