Orantech Inc.
Shenzhen Guangdong, CN
ORANTECH INC. appears in FDA device records in Shenzhen Guangdong, CN. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Orantech Inc. between 2018 and 2019. The busiest year on record is 2018, with 4. The most recent is 2019, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 4 |
| 2019 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K182327 | Patient Cables and Leadwires , Disposable ECG Leadwires | DSA | Substantially Equivalent | |
| K173194 | Temperature Probe | FLL | Substantially Equivalent | |
| K181270 | Disposable SpO2 Sensors, Reusable SpO2 Sensors | DQA | Substantially Equivalent | |
| K173197 | Reusable NIBP Cuff | DXQ | Substantially Equivalent | |
| K171828 | ETCO2 Sensor | CCK | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3013783488 | 3013783488 | ORANTECH INC. | Zone#A,4F,1st Bld,7th Industrial Zone,Yulv Community, GongMing, Guangming New District,, Shenzhen Guangdong 518106 CN | 2026 | and 30 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CAEAirway, Oropharyngeal, Anesthesiology
- DSJAlarm, Blood-Pressure
- DRQAmplifier And Signal Conditioner, Transducer Signal
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
- FQMBandage, Elastic
- DXQBlood Pressure Cuff
- IKDCable, Electrode
- DSACable, Transducer And Electrode, Patient, (Including Connector)
- CATCannula, Nasal, Oxygen
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- SDVClinical Electronic Thermometer
- DSKComputer, Blood-Pressure
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function
- FLLContinuous Measurement Thermometer
- DSIDetector And Alarm, Arrhythmia
- KZFDevice, Medical Examination, Ac Powered
- BYHDrain, Tee (Water Trap)
- DRXElectrode, Electrocardiograph
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- KZDInfusor, Pressure, For I.V. Bags
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- HFMMonitor, Uterine Contraction, External (For Use In Clinic)
- IQIOrthosis, Limb Brace
- DQAOximeter
- JOMPlethysmograph, Photoelectric, Pneumatic Or Hydraulic
- DSFRecorder, Paper Chart
- GDTStaple, Removable (Skin)
- LDEStethoscope, Manual
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- HGMSystem, Monitoring, Perinatal
- MSXSystem, Network And Communication, Physiological Monitors
- JFCSystem, Pressure Measurement, Intermittent
- KGXTape And Bandage, Adhesive
- KCYTourniquet, Pneumatic
- DRSTransducer, Blood-Pressure, Extravascular
- HFNTransducer, Pressure, Intrauterine
- HGLTransducer, Ultrasonic, Obstetric
- DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
- BYXTubing, Pressure And Accessories
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain