FDA.reportPublic FDA data

Carescape Dock F0

Primary DI
00198953002186
Brand
Carescape Dock F0
Company
GE Healthcare Finland Oy
Model
1
Catalog number
5700602
Device description
Carescape Dock F0
Published
2026-10-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
BZQMonitor, Breathing Frequency
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
DPSElectrocardiograph
DPZOximeter, Ear
DQAOximeter
DQKComputer, Diagnostic, Programmable
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
DSIDetector And Alarm, Arrhythmia
DSJAlarm, Blood-Pressure
DSKComputer, Blood-Pressure
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
FLLContinuous Measurement Thermometer
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
MLDMonitor, St Segment With Alarm
MUDOximeter, Tissue Saturation
QEMCerebral Oximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZQMonitor, Breathing FrequencyAnesthesiology2
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2
DPSElectrocardiographCardiovascular2
DPZOximeter, EarCardiovascular2
DQAOximeterCardiovascular2
DQKComputer, Diagnostic, ProgrammableCardiovascular2
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)Cardiovascular2
DSIDetector And Alarm, ArrhythmiaCardiovascular2
DSJAlarm, Blood-PressureCardiovascular2
DSKComputer, Blood-PressureCardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2
FLLContinuous Measurement ThermometerGeneral Hospital2
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2
MLDMonitor, St Segment With AlarmCardiovascular2
MUDOximeter, Tissue SaturationCardiovascular2
QEMCerebral OximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K260656000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260656000Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0MGE Healthcare Finland Oy2026-09-01MHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198953002186PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198953002186001989530021861989530021860198953002186

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Regulatory Flags#

DUNS number
401966697
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840682102964EntropyEntropy Cable, M1050784M10507842016-06-30
00840682103022OxyTip SpO2OXY-FMR-002016-06-16
00840682103077OxyTip SpO2OXY-WMR-002016-06-16
00195278949752TruSignal SpO2 MM 3.0M159769772026-10-04
00195278949769TruSignal SpO2 MM 1.8M159560152026-10-04
00840682106498Mobile CareWeb Viewer2016-06-21
00198953009567Carescape ONE259560312026-10-04
00840682102957EntropyGE Entropy sensor, M10386812016-08-15
00840682102971EntropyEasyFit sensor, M11744132016-08-15
00840682103015NAPiCCO Injectate Sensor Cable2016-06-10
00840682103039NAPiCCO Continuous Cardiac Output Cable2016-06-16
00840682102841NAD-Lite Spirometry Kit 3m/10ft, 80043822016-08-15
00840682102858NAPedi-Lite Spirometry Kit 3m, M10326342016-08-15
00840682102865NAPedi-lite Spirometry Kit 2m, 80027182016-08-15
00840682102926NAMini D-fend Water Trap, 800217480021742016-08-12
00840682102896NACalibration Gas, 7555872016-06-10
00840682102902NACalibration Gas, 755571-HEL2016-06-10
00198953049181NAPiCCO Continuous Cardiac Output Cable2026-01-05
00195278697165PORTRAIT HSWXBHSWXB5700219-112024-04-30
00195278466662E-EEGXMJD1012022-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860016689404HyperViewHypermed Technologies CorpMUD2026-11-05
05061136120005HeartKey Edge ECGB-SECUR LIMITEDDQK2026-11-05
05061136120005HeartKey Edge ECGB-SECUR LIMITEDDPS2026-11-05
05061136120012HeartKey RhythmB-SECUR LIMITEDDPS2026-11-05
05061136120012HeartKey RhythmB-SECUR LIMITEDDQK2026-11-05
06970331862711TIXMORShenzhen Ruiankang Technology Co. Ltd.FLL2026-11-05
06970331860779blood pressure monitorShenzhen Ruiankang Technology Co. Ltd.DXN2026-11-04
00195278490742VSPGe Medical Systems Information Technologies, Inc.MHX2026-11-03
00681131280228EquateWAL-MART STORES, INC.FLL2026-11-03
06927709405452AmetmedShenzhen Jamr Technology Co., Ltd.DXN2026-11-03
09120095900816SteadyTempSteadySense GmbHFLL2026-11-03
09120095900823SteadyTempSteadySense GmbHFLL2026-11-03
00884400815477VisubreathAFFIRM MEDICAL TECHNOLOGIES II, LLCCCK2026-08-05
20884838119240Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHDSI2026-05-26
20884838119776Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHDSI2026-05-19
06946725550519APKAPK Technology Co.,Ltd.DQA2026-03-27
06946725550120APKAPK Technology Co.,Ltd.DQA2026-03-26
06946725550175APKAPK Technology Co.,Ltd.DQA2026-03-26
06946725550335APKAPK Technology Co.,Ltd.DQA2026-03-26
06946725550069APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550076APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550083APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550090APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550106APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550113APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550137APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550144APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550151APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550168APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550182APKAPK Technology Co.,Ltd.DQA2026-03-19