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FDA 510(k)

KANIEVSKI SENSORY AID OR DEVICE

K-Number: K843433 · 1984-11-14

ApplicantSpectro Industries, Inc.
Decision Date1984-11-14
Product CodeLRA
DecisionSubstantially Equivalent

Device Summary

KANIEVSKI SENSORY AID OR DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Spectro Industries, Inc.. It received FDA 510(k) clearance on 1984-11-14 under 510(k) number K843433. The device is classified under product code LRA. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KANIEVSKI SENSORY AID OR DEVICE?

KANIEVSKI SENSORY AID OR DEVICE is a medical device that received FDA 510(k) clearance on 1984-11-14. The listed applicant is Spectro Industries, Inc.. The 510(k) number is K843433.

When did KANIEVSKI SENSORY AID OR DEVICE receive FDA 510(k) clearance?

KANIEVSKI SENSORY AID OR DEVICE received FDA 510(k) clearance on 1984-11-14, under 510(k) number K843433.

Who is the listed applicant for KANIEVSKI SENSORY AID OR DEVICE?

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

What is the FDA product code for KANIEVSKI SENSORY AID OR DEVICE?

The FDA product code for KANIEVSKI SENSORY AID OR DEVICE is LRA.

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 Spectro Industries, 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.

K896822SURGISMOKE

Related Devices (Code: LRA)

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.

K883853ETASevrain-Tech, Inc.K862471WEARABLE TWENTY-FOUR CHANNEL VIBROTACTILE VOCODERInstitute of LogopedicsK851441TACTICON 1600MedeconK851655TEACHER TMMonargue Intl.K831501TACTIL EAREar Three SystemsK830418TACTAIDAudiological Engineering 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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