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)

DAHLBERG MODEL XJ 8080 BODY-WORN HEARING AID

K-Number: K881612 · 1988-06-01

ApplicantDahlberg Electronics, Inc.
Decision Date1988-06-01
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

DAHLBERG MODEL XJ 8080 BODY-WORN HEARING AID is the device name listed in this FDA 510(k) record. The listed applicant is Dahlberg Electronics, Inc.. It received FDA 510(k) clearance on 1988-06-01 under 510(k) number K881612. 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 DAHLBERG MODEL XJ 8080 BODY-WORN HEARING AID?

DAHLBERG MODEL XJ 8080 BODY-WORN HEARING AID is a medical device that received FDA 510(k) clearance on 1988-06-01. The listed applicant is Dahlberg Electronics, Inc.. The 510(k) number is K881612.

When did DAHLBERG MODEL XJ 8080 BODY-WORN HEARING AID receive FDA 510(k) clearance?

DAHLBERG MODEL XJ 8080 BODY-WORN HEARING AID received FDA 510(k) clearance on 1988-06-01, under 510(k) number K881612.

Who is the listed applicant for DAHLBERG MODEL XJ 8080 BODY-WORN HEARING AID?

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

What is the FDA product code for DAHLBERG MODEL XJ 8080 BODY-WORN HEARING AID?

The FDA product code for DAHLBERG MODEL XJ 8080 BODY-WORN HEARING AID 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 Dahlberg Electronics, 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.

K896157DAHLBERG MODEL LH BEHIND-THE-EAR HEARING AIDK896159DAHLBERG MODEL LP BEHIND-THE-EAR HEARING AIDK896158DAHLBERG MODEL LA BEHIND-THE-EAR HEARING AIDK881417DAHLBERG MODEL GP BODY AIDK874831AUDIOTONE MODEL A2000 BEHIND-THE-EAR HEARING AIDK874830MIRACLE EAR MODEL BP BEHIND-THE-EAR HEARING AID

View all 31 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.

↑