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)

JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT

K-Number: K083488 · 2009-02-19

ApplicantAudifon-USA, Inc.
Decision Date2009-02-19
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT is the device name listed in this FDA 510(k) record. The listed applicant is Audifon-USA, Inc.. It received FDA 510(k) clearance on 2009-02-19 under 510(k) number K083488. The device is classified under product code KLW. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT?

JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT is a medical device that received FDA 510(k) clearance on 2009-02-19. The listed applicant is Audifon-USA, Inc.. The 510(k) number is K083488.

When did JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT receive FDA 510(k) clearance?

JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT received FDA 510(k) clearance on 2009-02-19, under 510(k) number K083488.

Who is the listed applicant for JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT?

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

What is the FDA product code for JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT?

The FDA product code for JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT is KLW.

Other records listing Audifon-USA, 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.

K130514AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRTK130417AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T SK121793AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON

Related Devices (Code: KLW)

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.

K260413Levo Gen 2 Tinnitus Therapy SystemLevo Medical CorporationK260614Tinnitus TherapySivantos GmbHK233435Peace N Quiet (0.7.0)Pnq HealthK223694Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)Duearity ABK221168Tinnitogram Signal GeneratorGoldenear Company, Inc.K221125SilentCloudAureliym GmbH

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.

↑