FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094082760
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901001
Catalog number
26241
Device description
TM 262 Test Cavity
Published
2023-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ETYTester, auditory impedance

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETYTester, Auditory ImpedanceEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K861516000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K861516000WELCH ALLYN TYMPANOMETERWelch Allyn, Inc.1986-06-10ETY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00732094082760PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094082760007320940827607320940827600732094082760

GMDN Terms#

Term, Definition table
TermDefinition
Impedance audiometerAn electronic instrument used to evaluate the functional condition of the middle ear by changing the air pressure in the external auditory canal to measure and graph the mobility characteristics of the tympanic membrane. It identifies abnormalities in tympanic membrane mobility due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor follow up treatment for inflammation of the middle ear.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(315)685-2834GDSN_SUPPORT@MYHILLROM.ONMICROSOFT.COM

Regulatory Flags#

DUNS number
198227881
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00732094335392Welch Allyn, Inc.90105875RT2022-10-03
00732094335422Welch Allyn, Inc.90105874RT2021-08-25
00732094335439Welch Allyn, Inc.90105874RE2021-08-25
00732094335446Welch Allyn, Inc.90105873RT2021-09-28
00732094335453Welch Allyn, Inc.90105873RE2020-05-15
00732094338751Welch Allyn, Inc.90105874WX2020-08-26
00732094338768Welch Allyn, Inc.90105874WT2020-08-26
00732094338775Welch Allyn, Inc.90105874WE2020-08-26
00732094335385Welch Allyn, Inc.90105875RX2023-04-26
00732094335408Welch Allyn, Inc.90105875RE2023-04-26
00732094335415Welch Allyn, Inc.90105874RX2023-04-26
00732094209167Welch Allyn, Inc.90105875WT-B2017-12-05
00732094209334Welch Allyn, Inc.90105875MX-B2017-12-05
00732094209372Welch Allyn, Inc.90105875MT-B2017-12-05
00732094209518Welch Allyn, Inc.90105875CT-B2017-12-05
00732094209570Welch Allyn, Inc.90105875CE-B2017-12-05
00732094209679Welch Allyn, Inc.90105874MT-B2017-12-05
00732094209792Welch Allyn, Inc.90105874CX-B2017-12-05
00732094209860Welch Allyn, Inc.90105874CT-B2017-12-05
00732094209921Welch Allyn, Inc.90105874CE-B2017-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05713315009570Madsen ZodiacNatus Medical Denmark ApSETY2026-06-03
05713315009402Madsen ZodiacNatus Medical Denmark ApSETY2026-06-02
08051597160051ResonanceM.R.S. SRLETY2025-09-01
08051597160099ResonanceM.R.S. SRLETY2025-09-01
04260223142994Sentiero Desktop DiagnosticPATH medical GmbHETY2024-05-22
05060488902673Amplivox AMPLIVOX LIMITEDETY2024-01-08
05060488902635Amplivox AMPLIVOX LIMITEDETY2023-12-22
05060488902680Amplivox AMPLIVOX LIMITEDETY2023-12-22
00732094084580Welch Allyn, Inc.WELCH ALLYN, INC.ETY2023-08-17
00732094084597Welch Allyn, Inc.WELCH ALLYN, INC.ETY2023-08-17
00732094084702Welch Allyn, Inc.WELCH ALLYN, INC.ETY2023-08-17
00732094084719Welch Allyn, Inc.WELCH ALLYN, INC.ETY2023-08-17
00732094084726Welch Allyn, Inc.WELCH ALLYN, INC.ETY2023-08-17
00732094084733Welch Allyn, Inc.WELCH ALLYN, INC.ETY2023-08-17
05713315009396Madsen ZodiacNatus Medical Denmark ApSETY2022-12-15
05713315009907Madsen ZodiacNatus Medical Denmark ApSETY2022-12-15
05713315009914Madsen ZodiacNatus Medical Denmark ApSETY2022-12-15
05713315009389Madsen ZodiacNatus Medical Denmark ApSETY2022-12-12
05713315009464Madsen ZodiacNatus Medical Denmark ApSETY2022-12-05
00571331500946Madsen ZodiacGn Otometrics A/SETY2022-12-05