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)

HEARING AID ANALYSIS SYSTEM

K-Number: K853271 · 1986-01-16

ApplicantRobert Bosch Corp.
Decision Date1986-01-16
Product CodeETW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HEARING AID ANALYSIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Robert Bosch Corp.. It received FDA 510(k) clearance on 1986-01-16 under 510(k) number K853271. The device is classified under product code ETW. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEARING AID ANALYSIS SYSTEM?

HEARING AID ANALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 1986-01-16. The listed applicant is Robert Bosch Corp.. The 510(k) number is K853271.

When did HEARING AID ANALYSIS SYSTEM receive FDA 510(k) clearance?

HEARING AID ANALYSIS SYSTEM received FDA 510(k) clearance on 1986-01-16, under 510(k) number K853271.

Who is the listed applicant for HEARING AID ANALYSIS SYSTEM?

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

What is the FDA product code for HEARING AID ANALYSIS SYSTEM?

The FDA product code for HEARING AID ANALYSIS SYSTEM is ETW.

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 Robert Bosch Corp. 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.

K854492ERG 551 ERGOMETER, BICYCLEK854493ERG 555 COUCH ERGOMETERK854491ERG 550 ERGOMETER BICYCLEK853541SP 4K853154HV-4K851485DEFI 502

View all 21 devices →

Related Devices (Code: ETW)

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.

K122028AURICAL HITGn OtometricsK113831PRIMUS HEARING INSTRUMENT TEST UNITAuditdata A/SK110286GN OTOMETRICS TYPE 1053 FREEFITGn Otometrics A/SK093006FONIX ,MODEL 8000Frye Electronics, Inc.K071462UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)Siemens Hearing Instruments, Inc.K061104SPEECHLINK 100 TYPE 1053Gn Otometrics A/S

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.

↑