FDA.reportPublic FDA data

FUKUDA DENSHI

Primary DI
04538612913594
Brand
FUKUDA DENSHI
Company
FUKUDA DENSHI CO.,LTD.
Model
OAO-102A
Published
2022-09-14
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
K150030000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150030000Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.2015-03-16MHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04538612913594PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04538612913594045386129135944538612913594

GMDN Terms#

Term, Definition table
TermDefinition
36178 Stretcher equipment holderA device intended to be affixed to a stretcher and designed to provide a platform or holder for emergency equipment/devices during treatment.

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
04538612061813FUKUDA DENSHICIO-13CTP-2.75513844702026-09-28
04538612061820FUKUDA DENSHICIO-13CTP-3.65513844802026-09-28
04538612230837FUKUDA DENSHIOAO-127A5514057702026-09-28
04538612230844FUKUDA DENSHIOAO-128A5514057802026-09-28
04538612916229FUKUDA DENSHICIO-13DIN3-2.7A5513848202026-09-28
04538612916632FUKUDA DENSHIBDS-2100M1514117202026-09-28
04538612916649FUKUDA DENSHIBDS-2100MR1514117302026-09-28
04538612916656FUKUDA DENSHIBDS-2100MRT1514117402026-09-28
04538612916663FUKUDA DENSHIBDS-2100N1514117502026-09-28
04538612916670FUKUDA DENSHIBDS-2100NR1514117602026-09-28
04538612916687FUKUDA DENSHIBDS-2100NRT1514117702026-09-28
04538612916694FUKUDA DENSHIHPD-1105514117802026-09-28
04538612151569FUKUDA DENSHISD-1G5202010502026-07-17
04538612161049FUKUDA DENSHIFCF-1285204004702026-07-17
04538612209543FUKUDA DENSHIFCF-10005592005692026-07-17
04538612226113FUKUDA DENSHIFCF-16GA5502076402026-07-17
04538612226922FUKUDA DENSHISD-8G5502666702026-07-17
04538612228070FUKUDA DENSHIFSD-8GA5510865002026-07-17
04538612230370FUKUDA DENSHICJO-31RS55513798002026-07-17
04538612230387FUKUDA DENSHIFSD-2G5513823802026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04538612061813FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612061820FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612230837FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612230844FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916229FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916632FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916649FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916656FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916663FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916670FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916687FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916694FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
06944413835153Telemetry MonitorEdan Instruments, Inc.MHX2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.MHX2026-08-26
B353UB25511UbiqVue MultiparameterLifesignals, Inc.MHX2026-07-20
04538612151569FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17
04538612161049FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17
04538612209543FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17
04538612226113FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17
04538612226922FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17
04538612228070FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17
04538612230370FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17
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