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FDA 510(k)

AURAL-CAM, VIDEO EAR, VID RX

K-Number: K941659 · 1994-04-26

ApplicantGracefully Yours, Inc.
Decision Date1994-04-26
Product CodeERA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AURAL-CAM, VIDEO EAR, VID RX is the device name listed in this FDA 510(k) record. The listed applicant is Gracefully Yours, Inc.. It received FDA 510(k) clearance on 1994-04-26 under 510(k) number K941659. The device is classified under product code ERA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AURAL-CAM, VIDEO EAR, VID RX?

AURAL-CAM, VIDEO EAR, VID RX is a medical device that received FDA 510(k) clearance on 1994-04-26. The listed applicant is Gracefully Yours, Inc.. The 510(k) number is K941659.

When did AURAL-CAM, VIDEO EAR, VID RX receive FDA 510(k) clearance?

AURAL-CAM, VIDEO EAR, VID RX received FDA 510(k) clearance on 1994-04-26, under 510(k) number K941659.

Who is the listed applicant for AURAL-CAM, VIDEO EAR, VID RX?

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

What is the FDA product code for AURAL-CAM, VIDEO EAR, VID RX?

The FDA product code for AURAL-CAM, VIDEO EAR, VID RX is ERA.

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 Gracefully Yours, 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.

K933633LOW-VISION READING AID, HELPMATE 2020, VISION-AIDE, LV HELPMATE

Related Devices (Code: ERA)

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.

K123821AIO HD OTOSCOPEBlue FocusK121326LANTOS 3D EAR SCANNERLantos TechnologiesK110326OSRAM ITOSOsram Sylvania, Inc.K945264OPTUS OTOSCOPESOptus, Inc.K955043WELCH ALLYN BI-OTOSCOPEWelch Allyn, Inc.K952578WELCH ALLY OTOSCOPEWelch Allyn, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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