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)

SM-VEGA, SM-PC, SM-AGC, SM-AGC-H

K-Number: K943682 · 1994-08-17

ApplicantStarkey Laboratories, Inc.
Decision Date1994-08-17
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SM-VEGA, SM-PC, SM-AGC, SM-AGC-H 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 1994-08-17 under 510(k) number K943682. 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 SM-VEGA, SM-PC, SM-AGC, SM-AGC-H?

SM-VEGA, SM-PC, SM-AGC, SM-AGC-H is a medical device that received FDA 510(k) clearance on 1994-08-17. The listed applicant is Starkey Laboratories, Inc.. The 510(k) number is K943682.

When did SM-VEGA, SM-PC, SM-AGC, SM-AGC-H receive FDA 510(k) clearance?

SM-VEGA, SM-PC, SM-AGC, SM-AGC-H received FDA 510(k) clearance on 1994-08-17, under 510(k) number K943682.

Who is the listed applicant for SM-VEGA, SM-PC, SM-AGC, SM-AGC-H?

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 SM-VEGA, SM-PC, SM-AGC, SM-AGC-H?

The FDA product code for SM-VEGA, SM-PC, SM-AGC, SM-AGC-H is ESD.

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: 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.

↑