FDA.reportPublic FDA data

FUKUDA DENSHI

Primary DI
04538612901836
Brand
FUKUDA DENSHI
Company
FUKUDA DENSHI CO.,LTD.
Model
CM-85C
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033711000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033711000FUKUDA DENSHI DYNASCOPE MODEL DS-5000 CENTRAL TELEMETRY SYSTEMFukuda Denshi USA, Inc.2004-06-03MHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04538612901836PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04538612901836045386129018364538612901836

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, reusableA collection of noninvasive devices intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690671011
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04538612054181FUKUDA DENSHIABT-720D2026-04-23
04538612914256FUKUDA DENSHIABT-810D2023-01-06
04538612914263FUKUDA DENSHIOAT-03A2023-01-06
04538612061912FUKUDA DENSHIABT-X1C2026-04-23
04538612916359FUKUDA DENSHIDS-X1M2026-04-23
04538612916373FUKUDA DENSHIDS-X1N2026-04-23
04538612916410FUKUDA DENSHIOAT-X1A2026-04-23
04538612230554FUKUDA DENSHIOAT-07A0.752026-04-02
04538612916502FUKUDA DENSHIOAO-125A2026-04-02
04538612916540FUKUDA DENSHICJO-32RS0.12026-04-02
04538612228483FUKUDA DENSHIFCS-64G5511207902026-03-06
04538612916328FUKUDA DENSHILXN-10002025-12-16
04538612230455FUKUDA DENSHIOAO-123A2025-12-17
04538612916236FUKUDA DENSHICIT-13DIN3-0.3A2025-12-17
04538612916243FUKUDA DENSHICMO-03NTG-0.9A2025-12-17
04538612916250FUKUDA DENSHICMO-04NTG-0.9A2025-12-17
04538612916267FUKUDA DENSHICMO-05NTG-0.9A2025-12-17
04538612061905FUKUDA DENSHIABT-1300C2025-12-16
04538612916281FUKUDA DENSHILX-1300M2025-12-16
04538612916304FUKUDA DENSHILX-1300N2025-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838132320Patient Information Center iXPhilips Medizin Systeme Böblingen GmbHMHX2026-07-13
00884838132337Care AssistPhilips Medizin Systeme Böblingen GmbHMHX2026-07-13
00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHMHX2026-07-13
04048675723639Vista 300Shanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675723646Vista 300Shanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675785477Vista CMSShanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675785484Vista CMSShanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675785491Vista CMSShanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675786108Vista CMSShanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675797173Vista 300 SShanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675797180Vista 300 SShanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675797197Vista 300 SShanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
00198953205716CARESCAPE Telemetry ServerGe Medical Systems Information Technologies, Inc.MHX2026-06-05
00884838119017Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119024Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119031Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119048Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119055Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119062Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119185Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119192Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119208Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119215Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119222Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119079Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119086Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119093Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119109Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119116Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119123Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26