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)

STARKEY MODEL P1 MODULE

K-Number: K873031 · 1988-02-08

ApplicantStarkey Laboratories, Inc.
Decision Date1988-02-08
Product CodeLRB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

STARKEY MODEL P1 MODULE 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 1988-02-08 under 510(k) number K873031. The device is classified under product code LRB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STARKEY MODEL P1 MODULE?

STARKEY MODEL P1 MODULE is a medical device that received FDA 510(k) clearance on 1988-02-08. The listed applicant is Starkey Laboratories, Inc.. The 510(k) number is K873031.

When did STARKEY MODEL P1 MODULE receive FDA 510(k) clearance?

STARKEY MODEL P1 MODULE received FDA 510(k) clearance on 1988-02-08, under 510(k) number K873031.

Who is the listed applicant for STARKEY MODEL P1 MODULE?

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 STARKEY MODEL P1 MODULE?

The FDA product code for STARKEY MODEL P1 MODULE is LRB.

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 KITK964245PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITSK964340PORTAREM-3000, PFS-6000K964216STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER

View all 60 devices →

Related Devices (Code: LRB)

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.

K974219FACEPLATE ASSEMBLYFinetone Hearing InstrumentsK961593INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDSSegi Hearing Aid Co.K942722MODULE PROGRAMElectone, Inc.K942236AUDINA PREWIRES (FACEPLATE HEARING AID SERIES)Audina Hearing InstrumentK935048ARTISAN PROGRAMMER & HEARING AIDTelex Communications, Inc.K933039GOLD L MODULE, ITEElectone, 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.

↑