Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

RX12 LINEAR FULL SHELL AND IN THE CANAL

K-Number: K953728 · 1995-09-12

ApplicantMidwest City Hearing Aid Center
Decision Date1995-09-12
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

RX12 LINEAR FULL SHELL AND IN THE CANAL is the device name listed in this FDA 510(k) record. The listed applicant is Midwest City Hearing Aid Center. It received FDA 510(k) clearance on 1995-09-12 under 510(k) number K953728. The device is classified under product code ESD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RX12 LINEAR FULL SHELL AND IN THE CANAL?

RX12 LINEAR FULL SHELL AND IN THE CANAL is a medical device that received FDA 510(k) clearance on 1995-09-12. The listed applicant is Midwest City Hearing Aid Center. The 510(k) number is K953728.

When did RX12 LINEAR FULL SHELL AND IN THE CANAL receive FDA 510(k) clearance?

RX12 LINEAR FULL SHELL AND IN THE CANAL received FDA 510(k) clearance on 1995-09-12, under 510(k) number K953728.

Who is the listed applicant for RX12 LINEAR FULL SHELL AND IN THE CANAL?

The FDA 510(k) record lists Midwest City Hearing Aid Center as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RX12 LINEAR FULL SHELL AND IN THE CANAL?

The FDA product code for RX12 LINEAR FULL SHELL AND IN THE CANAL is ESD.

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 Midwest City Hearing Aid Center 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.

K970430ADAPTIVE COMPRESSION - CLASS D/ CLASS D AGCIK963604DYNAMIC EQ II - 2 CHANNEL WIDE DYNAMIC RANGE COMPRESSIONK963607HORIZON 1 AND 2 PROGRAMABLE FULL SHELL AND IN THE CANALK953729K AMP FULL SHELL AND IN THE EARK953631SNIP INPUT COMPRESSION CLASS AK952986SPI-SECRET PERSONAL INSTRUMENT CIC

View all 12 devices →

Related Devices (Code: ESD)

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.

K232999Lyric4 Hearing AidSonova AGK130790LYRIC2Phonak, LLCK081136LYRIC HEARING AIDInsound Medical, Inc.K021867INSOUND XT SERIES HEARING AIDInsound Medical, Inc.K003558TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)Siemens Hearing Instruments, Inc.K984518SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELLSonic Innovations, 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.

↑