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FDA 510(k)

THE PAN.OPTX SPORTGLASS

K-Number: K913388 · 1991-10-02

ApplicantPanoptx, Inc.
Decision Date1991-10-02
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

THE PAN.OPTX SPORTGLASS is the device name listed in this FDA 510(k) record. The listed applicant is Panoptx, Inc.. It received FDA 510(k) clearance on 1991-10-02 under 510(k) number K913388. 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 THE PAN.OPTX SPORTGLASS?

THE PAN.OPTX SPORTGLASS is a medical device that received FDA 510(k) clearance on 1991-10-02. The listed applicant is Panoptx, Inc.. The 510(k) number is K913388.

When did THE PAN.OPTX SPORTGLASS receive FDA 510(k) clearance?

THE PAN.OPTX SPORTGLASS received FDA 510(k) clearance on 1991-10-02, under 510(k) number K913388.

Who is the listed applicant for THE PAN.OPTX SPORTGLASS?

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

What is the FDA product code for THE PAN.OPTX SPORTGLASS?

The FDA product code for THE PAN.OPTX SPORTGLASS 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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