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FDA 510(k)

SPECTACLE, MAGNIFYING

K-Number: K873967 · 1988-02-26

ApplicantSwank Plus , Ltd.
Decision Date1988-02-26
Product CodeHOT
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SPECTACLE, MAGNIFYING is the device name listed in this FDA 510(k) record. The listed applicant is Swank Plus , Ltd.. It received FDA 510(k) clearance on 1988-02-26 under 510(k) number K873967. The device is classified under product code HOT. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTACLE, MAGNIFYING?

SPECTACLE, MAGNIFYING is a medical device that received FDA 510(k) clearance on 1988-02-26. The listed applicant is Swank Plus , Ltd.. The 510(k) number is K873967.

When did SPECTACLE, MAGNIFYING receive FDA 510(k) clearance?

SPECTACLE, MAGNIFYING received FDA 510(k) clearance on 1988-02-26, under 510(k) number K873967.

Who is the listed applicant for SPECTACLE, MAGNIFYING?

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

What is the FDA product code for SPECTACLE, MAGNIFYING?

The FDA product code for SPECTACLE, MAGNIFYING is HOT.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Swank Plus , Ltd. 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.

K873965FRAME, SPECTACLEK873966SUNGLASSES (NONPRESCRIPTION)

Related Devices (Code: HOT)

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.

K863994VIEWSCANSensory Aids Corp.

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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