Masimo Medical Technologies (Malaysia) Sdn Bhd
Pasir Gudang Johor, MY
Masimo Medical Technologies (Malaysia) SDN BHD appears in FDA device records in Pasir Gudang Johor, MY. FDA records list no 510(k) clearances, 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) clearances
- 0
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 1
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3027256461 | 3027256461 | Masimo Medical Technologies (Malaysia) SDN BHD | Lot 198511 (PLO 547-A) & Lot 198512 (PLO 547-B), Jalan Keluli 11, Zon 12A Kawasan Perindustrian Pasir Gudang, Pasir Gudang Johor 81700 MY | 2026 | and 13 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- NHOAnalyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)
- CBQAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
- CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
- NHQAnalyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)
- CBRAnalyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
- NHPAnalyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
- ORTBurst Suppression Detection Software For Electroencephalograph
- CATCannula, Nasal, Oxygen
- FLLContinuous Measurement Thermometer
- GXYElectrode, Cutaneous
- GWQFull-Montage Standard Electroencephalograph
- QWEHyperoxia Monitoring Device Adjunct To Pulse Oximetry
- OLWIndex-Generating Electroencephalograph Software
- BZQMonitor, Breathing Frequency
- MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- OLTNon-Normalizing Quantitative Electroencephalograph Software
- DQAOximeter
- DPZOximeter, Ear
- OMCReduced- Montage Standard Electroencephalograph
- JKSSpectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
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