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FDA 510(k)

MODIFICATION TO: OCU-FILM TIP COVER

K-Number: K070534 · 2007-03-27

ApplicantReichert, Inc.
Decision Date2007-03-27
Product CodeHKY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: OCU-FILM TIP COVER is the device name listed in this FDA 510(k) record. The listed applicant is Reichert, Inc.. It received FDA 510(k) clearance on 2007-03-27 under 510(k) number K070534. The device is classified under product code HKY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO: OCU-FILM TIP COVER?

MODIFICATION TO: OCU-FILM TIP COVER is a medical device that received FDA 510(k) clearance on 2007-03-27. The listed applicant is Reichert, Inc.. The 510(k) number is K070534.

When did MODIFICATION TO: OCU-FILM TIP COVER receive FDA 510(k) clearance?

MODIFICATION TO: OCU-FILM TIP COVER received FDA 510(k) clearance on 2007-03-27, under 510(k) number K070534.

Who is the listed applicant for MODIFICATION TO: OCU-FILM TIP COVER?

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

What is the FDA product code for MODIFICATION TO: OCU-FILM TIP COVER?

The FDA product code for MODIFICATION TO: OCU-FILM TIP COVER is HKY.

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Other records listing Reichert, 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.

K233516Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)K081756OCULAR RESPONSE ANALYZERK071839SOCT COPERNICUS, MODEL 15205K063750XCEL 255 SLIT LAMPK061330PSL PORTABLE SLIT LAMPK042831ATP (AUTO NON-CONTACT TONOMETER/PACHYMETER)

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Related Devices (Code: HKY)

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.

K241447iCare ST500 (TA04)Icare Finland OYK233516Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)Reichert, Inc.K234037CATS-L Tonometer™ PrismCats Tonometer, LLCK232143Applanation Tonometer HT-5000Huvitz Co., Ltd.K220852iCare IC200Icare Finland OYK211355iCare HOME2Icare Finland OY

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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