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FDA 510(k)

SPECTABLE FRAME MAGNIFYING BRILLETTE

K-Number: K844657 · 1984-12-11

ApplicantPro Design Intl. AS
Decision Date1984-12-11
Product CodeHOJ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SPECTABLE FRAME MAGNIFYING BRILLETTE is the device name listed in this FDA 510(k) record. The listed applicant is Pro Design Intl. AS. It received FDA 510(k) clearance on 1984-12-11 under 510(k) number K844657. The device is classified under product code HOJ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTABLE FRAME MAGNIFYING BRILLETTE?

SPECTABLE FRAME MAGNIFYING BRILLETTE is a medical device that received FDA 510(k) clearance on 1984-12-11. The listed applicant is Pro Design Intl. AS. The 510(k) number is K844657.

When did SPECTABLE FRAME MAGNIFYING BRILLETTE receive FDA 510(k) clearance?

SPECTABLE FRAME MAGNIFYING BRILLETTE received FDA 510(k) clearance on 1984-12-11, under 510(k) number K844657.

Who is the listed applicant for SPECTABLE FRAME MAGNIFYING BRILLETTE?

The FDA 510(k) record lists Pro Design Intl. AS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPECTABLE FRAME MAGNIFYING BRILLETTE?

The FDA product code for SPECTABLE FRAME MAGNIFYING BRILLETTE is HOJ.

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 Pro Design Intl. AS 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.

K844658SPECTABLE FRAME - PRODESIGN SUN CLUB

Related Devices (Code: HOJ)

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.

K873919TANGENT SCREENRichmond Products, Inc.K821081CHART PROJECTORMedical Equipment Designs, Inc.

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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