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FDA 510(k)

OPHTHALMIC CRYO UNIT

K-Number: K940373 · 1994-07-18

ApplicantDutch Ophthalmic USA, Inc.
Decision Date1994-07-18
Product CodeHPS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPHTHALMIC CRYO UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Dutch Ophthalmic USA, Inc.. It received FDA 510(k) clearance on 1994-07-18 under 510(k) number K940373. The device is classified under product code HPS. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPHTHALMIC CRYO UNIT?

OPHTHALMIC CRYO UNIT is a medical device that received FDA 510(k) clearance on 1994-07-18. The listed applicant is Dutch Ophthalmic USA, Inc.. The 510(k) number is K940373.

When did OPHTHALMIC CRYO UNIT receive FDA 510(k) clearance?

OPHTHALMIC CRYO UNIT received FDA 510(k) clearance on 1994-07-18, under 510(k) number K940373.

Who is the listed applicant for OPHTHALMIC CRYO UNIT?

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

What is the FDA product code for OPHTHALMIC CRYO UNIT?

The FDA product code for OPHTHALMIC CRYO UNIT is HPS.

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Other records listing Dutch Ophthalmic USA, Inc. as applicant

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Related Devices (Code: HPS)

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.

K202038CryoTreQVitreQ BVK923629OPHTHALMIC TRICHIASIS PROBEMira, Inc.K903303SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBESSpembly Medical , Ltd.K874555KEELER ACU 22XT OPHTHALMIC CRYO UNITKeeler Instruments, Inc.K873388KEELER CTU CRYO SYSTEMKeeler Instruments, Inc.K870195UNITED SURGICAL CORP. CRYOPTIC PLUSUnited Surgical Corp.

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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