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FDA 510(k)

HEARSAVER

K-Number: K962292 · 1996-10-29

ApplicantEmtech Laboratories
Decision Date1996-10-29
Product CodeEWD
DecisionSubstantially Equivalent

Device Summary

HEARSAVER is the device name listed in this FDA 510(k) record. The listed applicant is Emtech Laboratories. It received FDA 510(k) clearance on 1996-10-29 under 510(k) number K962292. The device is classified under product code EWD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEARSAVER?

HEARSAVER is a medical device that received FDA 510(k) clearance on 1996-10-29. The listed applicant is Emtech Laboratories. The 510(k) number is K962292.

When did HEARSAVER receive FDA 510(k) clearance?

HEARSAVER received FDA 510(k) clearance on 1996-10-29, under 510(k) number K962292.

Who is the listed applicant for HEARSAVER?

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

What is the FDA product code for HEARSAVER?

The FDA product code for HEARSAVER is EWD.

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 Emtech Laboratories 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.

K853381OE SERIES OF BEHIND-THE-EAR HEARING AIDS

Related Devices (Code: EWD)

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.

K020296ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057Apothecary Products, Inc.K972923SUPER SILIPLUGS EAR PLUGSInterview Medical Technology Corp.K971517SILICONE PUTTY EAR PLUGSBentec Medical, Inc.K960500THE VIRTUAL M-332Virtual Corp.K945376DOC'S PROPLUGS EAR PLUGSDoc'S Proplugs, Inc.K930203MODEL 322 CLINICAL AUDIOMETERVirtual 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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