FDA 510(k)

MODEL 2000 OPHTHALMIC SURGICAL SYSTEM

K-Number: K940084 · 1994-06-17

Decision Date1994-06-17

Product CodeHQC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

MODEL 2000 OPHTHALMIC SURGICAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Technical Products. It received FDA 510(k) clearance on 1994-06-17 under 510(k) number K940084. 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 MODEL 2000 OPHTHALMIC SURGICAL SYSTEM?

MODEL 2000 OPHTHALMIC SURGICAL SYSTEM is a medical device that received FDA 510(k) clearance on 1994-06-17. The listed applicant is Medical Technical Products. The 510(k) number is K940084.

When did MODEL 2000 OPHTHALMIC SURGICAL SYSTEM receive FDA 510(k) clearance?

MODEL 2000 OPHTHALMIC SURGICAL SYSTEM received FDA 510(k) clearance on 1994-06-17, under 510(k) number K940084.

Who is the listed applicant for MODEL 2000 OPHTHALMIC SURGICAL SYSTEM?

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

What is the FDA product code for MODEL 2000 OPHTHALMIC SURGICAL SYSTEM?

The FDA product code for MODEL 2000 OPHTHALMIC SURGICAL SYSTEM is HQC.

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Other records listing Medical Technical Products as applicant

K940083STANDARD PHACO TIP 15, 30, 45, 60 K940088MEDICAL TECHNICAL PRODUCTS STANDARD ULTRASONIC HANDPIECE K910335MTP TRANSPORT INFUSION PUMP, MODEL NO. MTPLEA K905251MTP TRANSPORT INFUSION PUMP MODEL NO. 1001A K904612I/A-PHACO SYSTEM (IRR./ASPIR./AND PHACO./SYSTEM)K871473PART #860065 IA PAK & PART #860060 IA PAK

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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.