EWO

Product Code: EWO


Products Classified as EWO

1472AudiometerAudiometer.

Total Product Life Cycle (TPLC) Devices

1472AudiometerAudiometer.

FDA Consensus Standards

Audiometer [31251]21 CFR §874.1050 🔎
Audiometer [32302]21 CFR §874.1050 🔎
Audiometer [29591]21 CFR §874.1050 🔎
Audiometer [33856]21 CFR §874.1050 🔎
Audiometer [29578]21 CFR §874.1050 🔎
Audiometer [31250]21 CFR §874.1050 🔎

Pre-market Notifications for EWO

K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEPath Medical GmbH
K191372LyraInteracoustics A/S
K180287GSI CortiGrason-Stadler Inc.
K173567SeraInteracoustics A/S
K172403GSI NovusGrason-Stadler Inc.
K171506EasyscreenMaico Diagnostics GmbH
K151025IHearTestIHEAR MEDICAL, INC.
K150491ER36 Series OAE Test SystemETYMOTIC RESEARCH, INC.
K143395Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade KitOTODYNAMICS, LTD.
K141524NEURO-AUDIOTELEEMG, LLC USA
K133012SENTIEROPATH MEDICAL GMBH
K130795TITANINTERACOUSTICS A/S
K123624OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEMMIMOSA ACOUSTICS, INC.
K122496AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEMBIO-LOGIC SYSTEMS CORP.
K121512SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEMBIO-LOGIC SYSTEMS CORP.

Global Unique Device Identification Database

00382830055130Audiometer
00382830055093Audiometer
00382830055055Audiometer
00382830055048Audiometer
00382830055031Audiometer
00382830054980Audiometer
00382830054973Audiometer
00382830054959Audiometer
00382830054942Audiometer
00382830054454Audiometer
00382830054447Audiometer
00382830053679Audiometer
00382830053662Audiometer
00382830053655Audiometer
00382830053648Audiometer

Maude Adverse Events

AURICAL AUD/PMM,NATUS MEDICAL DENMARK2020-03-07
1081 AURICAL (PMM, C&S, AUD) WITH HI-PRONATUS MEDICAL DENMARK2020-01-31
HEADSET HB-7 (12 KHZ) MATCHED TDH39 PHONES (JACK)NATUS MEDICAL DENMARK APS (GN OTOMETRICS)2019-09-26
AURICAL AUD/PMM, 1081NATUS MEDICAL DENMARK (GN OTOMETRICS)2019-09-04
AURICAL AUD/PMM, 1081NATUS MEDICAL DENMARK (GN OTOMETRICS)2019-09-03
AURICAL AUD/PMM, 1081NATUS MEDICAL DENMARK (GN OTOMETRICS)2019-08-27
TREMETRICS RA300TREMETRICS2015-07-09
TERUMO CDI 500 BLOOD PARAMETER MONITORTERUMO CARDIOVASCULAR SYSTEM CORP.2011-09-12
RA500 AUDIOMETERDIAGNOSTIC GROUP LLC DBA TREMETRICS2011-06-02
TREMETRICS MODEL 757 AUDIOMETERTREMETRICS2010-12-09
TREMETRICS MODEL 757 AUDIOMETERTREMETRICS2010-12-09
RA500 AUDIOMETERDIAGNOSTIC GROUP, LLC2010-06-23
NATUSNATUS MEDICAL INC2010-02-11
NATUSNATUS MEDICAL2009-04-13
NONEOTODYNAMICS, LTD.2008-02-07
ECHOSCREEN TEOAE HEARING SCREENERFISCHER-ZOTH DIAGNOSESYSTEME, GMBH2007-01-10
CLARITY IISONAMED CORP2006-10-24
CLARITY IISONAMED CORP2006-10-24
ALGO 2ECNATUS MEDICAL, INC.2006-08-23
MAICO MA27 SCREENING AUDIOMETERMAICO DIAGNOSTICS2006-04-07
UNKAUDIOMETRY DIAGNOSTIC DEVICEUNK1998-12-22

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