FDA.reportPublic FDA data

Adscope®

Primary DI
00634782083311
Brand
Adscope®
Company
AMERICAN DIAGNOSTIC CORP
Model
658MCA
Catalog number
658MCA
Device description
Electronic Scope-658,Adult, Metallic Caribbean
Published
2017-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQDStethoscope, Electronic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQDStethoscope, ElectronicCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162589000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162589000Adscope 658 Electronic StethoscopeAmerican Diagnostic Corp.2017-03-10DQD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00634782584702PackageGS13In Commercial Distribution
00634782083311PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00634782584702006347825847026347825847020634782584702
00634782083311006347820833116347820833110634782083311

GMDN Terms#

Term, Definition table
TermDefinition
Electronic acoustic stethoscopeAn external, hand-held, electronic listening device designed to be used by a healthcare professional for real-time detection and amplification of body sounds (e.g., heart, blood vessels, lungs) that may be difficult to perceive when using a mechanical stethoscope; it is not designed for electrocardiography (ECG). It is typically designed to be connected to a computing device, which may operate interpretive software sometimes provided with the stethoscope, for recording and/or displaying the results in the form of a graph [phonocardiogram (PCG)].

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-4 Degrees Fahrenheit158 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
1-800-232-2670info@adctoday.com

Regulatory Flags#

DUNS number
108999095
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00634782102159Diagnostix™805NWWA805NWWA2026-08-26
00634782102166Diagnostix™805NMWA805NMWA2026-08-26
00634782102173Diagnostix™805NDWA805NDWA2026-08-26
00634782102197Adcuff™885TAWA885TAWA2026-08-26
00634782102203Adcuff™885NWA885NWA2026-08-26
00634782102210Adcuff™886NWA886NWA2026-08-26
00634782101459Prosphyg™760-11ABCAA760-11ABCAA2026-08-25
00634782101633Diagnostix™2101CN2101CN2026-08-25
00634782101848Adscope®603BKAC603BKAC2026-08-25
00634782102098Proscope™664BKKM664BKKM2026-08-25
00634782102104Proscope™664YKM664YKM2026-08-25
00634782102111Proscope™665YKM665YKM2026-08-25
00634782102128Adsoft™660-08BK660-08BK2026-08-25
00634782102180Diagnostix™805NWA805NWA2026-08-25
00634782102265Advantage™6121KIT6121KIT2026-08-25
00634782045708Proscope™665Y665Y2016-09-21
00634782098384Adscope®603-04W603-04W2026-03-30
00634782099473Prosphyg™760-11ABCAAQ760-11ABCAAQ2023-01-11
00634782102258Adscope®608CFST608CFST2026-06-02
00634782603045ADC54202542022026-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08883000003064AeviceMDAEVICE HEALTH PTE. LTD.DQD2026-06-22
00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.DQD2026-06-03
00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.DQD2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DQD2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DQD2026-06-03
08883000007413AeviceMDAEVICE HEALTH PTE. LTD.DQD2026-05-18
00810209880019CORE 500 Digital Stethoscope FIGS Earpiece - Rapid Response PinkEko Devices, Inc.DQD2026-04-03
00810209880026CORE 500 Digital Stethoscope FIGS Earpiece - Orange TaffyEko Devices, Inc.DQD2026-04-03
00850010298955CORE 500 Digital Stethoscope - Rose Gold ChestpieceEko Devices, Inc.DQD2026-04-03
00850010298962CORE 500 Digital Stethoscope - Rose Gold EarpieceEko Devices, Inc.DQD2026-04-03
00850010298979CORE 500 Digital Stethoscope - Bundle-ROGEko Devices, Inc.DQD2026-04-03
00860011561736Stethophone ProSparrow Acoustics Inc.DQD2026-02-18
00810209880002CORE 500 Digital Stethoscope FIGS Earpiece - Caribbean BlueEko Devices, Inc.DQD2026-01-29
00810209880040EFAST (Eko Foundation Analysis Software with Transformers)Eko Devices, Inc.DQD2026-01-29
08809427311032SkeeperSmartsound CorportationDQD2026-01-12
00850010298894CORE 500 Digital Stethoscope - Cool Blue ChestpieceEko Devices, Inc.DQD2025-11-07
00850010298900CORE 500 Digital Stethoscope - Cool Blue EarpieceEko Devices, Inc.DQD2025-11-07
06429811134003Keikku Digital StethoscopeLapsi Health Holding B.V.DQD2025-10-16
00850010298740CORE 500 Digital Stethoscope - Ruby ChestpieceEko Devices, Inc.DQD2025-10-15
00850010298917CORE 500 Digital Stethoscope FIGS Earpiece - ElderberryEko Devices, Inc.DQD2025-10-15
00850010298924CORE 500 Digital Stethoscope FIGS Earpiece - Off WhiteEko Devices, Inc.DQD2025-10-15
00850010298726CORE 500 Digital Stethoscope - Electric Pink ChestpieceEko Devices, Inc.DQD2025-08-12
00850010298757CORE 500 Digital Stethoscope - Electric Pink EarpieceEko Devices, Inc.DQD2025-08-12
00850010298788CORE 500 Digital Stethoscope - Bundle-SLVEko Devices, Inc.DQD2025-08-12
00850010298795CORE 500 Digital Stethoscope - Bundle-BLKEko Devices, Inc.DQD2025-08-12
00850010298801CORE 500 Digital Stethoscope - Bundle-CHPEko Devices, Inc.DQD2025-08-12
00850010298818CORE 500 Digital Stethoscope FIGS Earpiece - Fight Club PinkEko Devices, Inc.DQD2025-08-12
00850010298733CORE 500 Digital Stethoscope - Ruby Earpiece Eko Devices, Inc.DQD2025-03-19
00850010298245CORE 500 Digital Stethoscope FIGS Earpiece - BlackEko Devices, Inc.DQD2025-03-18
00850010298252CORE 500 Digital Stethoscope FIGS Earpiece - GreyEko Devices, Inc.DQD2025-03-18