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FDA 510(k)

CHRONOSWISS,BALENO,BONIA,OTMAR ALT, NEW JERSEY

K-Number: K961746 · 1996-05-16

ApplicantEurotrends Eyewear, Inc.
Decision Date1996-05-16
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CHRONOSWISS,BALENO,BONIA,OTMAR ALT, NEW JERSEY is the device name listed in this FDA 510(k) record. The listed applicant is Eurotrends Eyewear, Inc.. It received FDA 510(k) clearance on 1996-05-16 under 510(k) number K961746. The device is classified under product code HQY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHRONOSWISS,BALENO,BONIA,OTMAR ALT, NEW JERSEY?

CHRONOSWISS,BALENO,BONIA,OTMAR ALT, NEW JERSEY is a medical device that received FDA 510(k) clearance on 1996-05-16. The listed applicant is Eurotrends Eyewear, Inc.. The 510(k) number is K961746.

When did CHRONOSWISS,BALENO,BONIA,OTMAR ALT, NEW JERSEY receive FDA 510(k) clearance?

CHRONOSWISS,BALENO,BONIA,OTMAR ALT, NEW JERSEY received FDA 510(k) clearance on 1996-05-16, under 510(k) number K961746.

Who is the listed applicant for CHRONOSWISS,BALENO,BONIA,OTMAR ALT, NEW JERSEY?

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

What is the FDA product code for CHRONOSWISS,BALENO,BONIA,OTMAR ALT, NEW JERSEY?

The FDA product code for CHRONOSWISS,BALENO,BONIA,OTMAR ALT, NEW JERSEY is HQY.

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Related Devices (Code: HQY)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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