Lutech

GUDID B299760MIC0

Multi-parameter patient monitor. 760-M-IC

LUTECH INDUSTRIES INC

Transportable physiologic monitoring system Transportable physiologic monitoring system Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical

• Primary Device ID: B299760MIC0
• NIH Device Record Key: f18d7266-7812-40d3-a780-9927b58b5591
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lutech
• Version Model Number: Datalys 760
• Company DUNS: 078698036
• Company Name: LUTECH INDUSTRIES INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B299760MIC0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150691

FDA Product Code

• DPS: Electrocardiograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-12

On-Brand Devices [Lutech]

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• B299780NPMO2P0: Multi-parameter patient monitor. 780-N-pMO2-P
• B299780NPMO20: Multi-parameter patient monitor. 780-N-pMO2
• B299780NPM0: Multi-parameter patient monitor. 780-N-pM
• B299780NP0: Multi-parameter patient monitor. 780-N-P
• B299780NIPMP0: Multi-parameter patient monitor. 780-N-I-pM-P
• B299780NIPMO2P0: Multi-parameter patient monitor. 780-N-I-pMO2-P
• B299780NIPMO20: Multi-parameter patient monitor. 780-N-I-pMO2
• B299780NIPM0: Multi-parameter patient monitor. 780-N-I-pM
• B299780NIP0: Multi-parameter patient monitor. 780-N-I-P
• B299780NICP0: Multi-parameter patient monitor. 780-N-IC-P
• B299780NICOP0: Multi-parameter patient monitor. 780-N-I-CO-P
• B299780NICO0: Multi-parameter patient monitor. 780-N-I-CO
• B299780NICCOP0: Multi-parameter patient monitor. 780-N-IC-CO-P
• B299780NICCO0: Multi-parameter patient monitor. 780-N-IC-CO
• B299780NIC0: Multi-parameter patient monitor. 780-N-IC
• B299780NI0: Multi-parameter patient monitor. 780-N-I
• B299780NCP0: Multi-parameter patient monitor. 780-N-C-P
• B299780NCO0: Multi-parameter patient monitor. 780-N-CO
• B299780NC0: Multi-parameter patient monitor. 780-N-C
• B299780N0: Multi-parameter patient monitor. 780-N
• B299780MPMP0: Multi-parameter patient monitor. 780-M-pM-P
• B299780MPMO2P0: Multi-parameter patient monitor. 780-M-pMO2-P
• B299780MPMO20: Multi-parameter patient monitor. 780-M-pMO2
• B299780MPM0: Multi-parameter patient monitor. 780-M-pM
• B299780MP0: Multi-parameter patient monitor. 780-M-P
• B299780MIPMP0: Multi-parameter patient monitor. 780-M-I-pM-P
• B299780MIPMO2P0: Multi-parameter patient monitor. 780-M-I-pMO2-P
• B299780MIPMO20: Multi-parameter patient monitor. 780-M-I-pMO2
• B299780MIPM0: Multi-parameter patient monitor. 780-M-I-pM
• B299780MIP0: Multi-parameter patient monitor. 780-M-I-P
• B299780MICP0: Multi-parameter patient monitor. 780-M-IC-P
• B299780MICOP0: Multi-parameter patient monitor. 780-M-I-CO-P
• B299780MICO0: Multi-parameter patient monitor. 780-M-I-CO
• B299780MICCOP0: Multi-parameter patient monitor. 780-M-IC-CO-P
• B299780MICCO0: Multi-parameter patient monitor. 780-M-IC-CO
• B299780MIC0: Multi-parameter patient monitor. 780-M-IC
• B299780MI0: Multi-parameter patient monitor. 780-M-I
• B299780MCP0: Multi-parameter patient monitor. 780-M-C-P
• B299780MC0: Multi-parameter patient monitor. 780-M-C
• B299780M0: Multi-parameter patient monitor. 780-M
• B299780LPMP0: Multi-parameter patient monitor. 780-L-pM-P
• B299780LPMO2P0: Multi-parameter patient monitor. 780-L-pMO2-P
• B299780LPMO20: Multi-parameter patient monitor. 780-L-pMO2
• B299780LPM0: Multi-parameter patient monitor. 780-L-pM
• B299780LP0: Multi-parameter patient monitor. 780-L-P
• B299780LIPMP0: Multi-parameter patient monitor. 780-L-I-pM-P