FDA.reportPublic FDA data

Hitachi

Primary DI
04580292776150
Brand
Hitachi
Company
HITACHI, LTD.
Model
ETG-4000
Published
2016-09-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042501000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042501000ETG-4000 OPTICAL TOPOGRAPHY SYSTEMHitachi Medical Corp.2004-10-12DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04580292776150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04580292776150045802927761504580292776150

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter, line-poweredA mains electricity (AC-powered) photoelectric device intended for the continuous transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector in a probe, or directly built-in, are used to make the measurements using the principle of spectrophotometry. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., pulse rate, electrocardiogram (ECG). The device is typically used bedside.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
692969845
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04560333350280PROBEATSmall Field Applicator for PROBEAT-V2026-01-20
04560333350204PROBEATPROBEAT-FR2024-01-19
04560333350211PROBEATMini Ridge Filter and auxiliary functions for PROB2023-12-20
04560333350228PROBEATReal Time Image Gating System for Proton Beam Ther2023-12-20
04562122958639HITACHIDAS-RS12019-07-01
04560333350198PROBEATSmall Field Applicator for PROBEAT-V2023-10-02
04560333350006PROBEATPROBEAT-CR2019-09-24
04562122951555HITACHIMP-2445-SET2018-09-24
04562122951562HITACHIMP-24502018-09-23
04562122951616HITACHIMP-2748-SET2018-09-24
04562122951630HITACHIMP-2445-G142018-09-24
04562122951647HITACHIMP-2445-G162018-09-24
04562122951654HITACHIMP-2445-G172018-09-24
04562122951661HITACHIMP-2445-G182018-09-24
04562122951678HITACHIMP-2445-G222018-09-24
04562122951685HITACHIMP-2452-G162018-09-24
04562122951692HITACHIMP-2452-G182018-09-24
04562122951708HITACHIMP-2748-G162018-09-24
04562122951715HITACHIMP-2748-G172018-09-24
04562122951722HITACHIMP-2748-G182018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048675785910Masimo SpO2 Module for Vista 300/SShanghai Draeger Medical Instrument Co.,Ltd.DQA2026-07-13
00010939962218N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00093351041099N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013550N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013567N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113849N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113856N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06931973400563CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973400730CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
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06931973410692CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410715CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410722CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410739CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09