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)

PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS

K-Number: K964245 · 1997-02-04

ApplicantStarkey Laboratories, Inc.
Decision Date1997-02-04
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS is the device name listed in this FDA 510(k) record. The listed applicant is Starkey Laboratories, Inc.. It received FDA 510(k) clearance on 1997-02-04 under 510(k) number K964245. 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 PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS?

PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS is a medical device that received FDA 510(k) clearance on 1997-02-04. The listed applicant is Starkey Laboratories, Inc.. The 510(k) number is K964245.

When did PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS receive FDA 510(k) clearance?

PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS received FDA 510(k) clearance on 1997-02-04, under 510(k) number K964245.

Who is the listed applicant for PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS?

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

What is the FDA product code for PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS?

The FDA product code for PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS 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 Starkey Laboratories, 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.

K201370Multiflex Tinnitus TechnologyK030180CRESCENT TINNITUS RETAINING SOUND GENERATORK970952PRECISE IMPRESSION KITK964340PORTAREM-3000, PFS-6000K964216STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKERK964244STARKEY CUSTOM SEQUEL PROGRAMMABLE AND K AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS

View all 60 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.

↑