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FDA 510(k)

#157 EXAM LIGHT

K-Number: K893949 · 1989-08-07

ApplicantMedmark, Inc.
Decision Date1989-08-07
Product CodeKFK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

#157 EXAM LIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Medmark, Inc.. It received FDA 510(k) clearance on 1989-08-07 under 510(k) number K893949. The device is classified under product code KFK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the #157 EXAM LIGHT?

#157 EXAM LIGHT is a medical device that received FDA 510(k) clearance on 1989-08-07. The listed applicant is Medmark, Inc.. The 510(k) number is K893949.

When did #157 EXAM LIGHT receive FDA 510(k) clearance?

#157 EXAM LIGHT received FDA 510(k) clearance on 1989-08-07, under 510(k) number K893949.

Who is the listed applicant for #157 EXAM LIGHT?

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

What is the FDA product code for #157 EXAM LIGHT?

The FDA product code for #157 EXAM LIGHT is KFK.

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 Medmark, 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.

K914498POWDER FREE, NON-STERILE, LATEX EXAMINATION GLOVESK894987MODEL #520/525 ED/RECOVERY STRETCHER

Related Devices (Code: KFK)

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.

K894301MICRO-AIRE STERNUM SAW 4800Micro Surgical Instruments Corp.K870157OSCILLATING SAW/ RECIPROCATING SAW/ DRILL-REAMERMicro-Aire Surgical Instruments, Inc.K801737STERNUM SAWAmsco Co.

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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