Datalys Multi-Parameter Patient Monitor

Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

Lutech Industries, Inc.

The following data is part of a premarket notification filed by Lutech Industries, Inc. with the FDA for Datalys Multi-parameter Patient Monitor.

Pre-market Notification Details

• Device ID: K150691
• 510k Number: K150691
• Device Name: Datalys Multi-Parameter Patient Monitor
• Classification: Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
• Applicant: Lutech Industries, Inc. 105 Remington Blvd., Suite C Ronkonkoma, NY 11779
• Contact: Ronald Vachula
• Correspondent: Jimmy Wu; LEE & XIAO 2600 MISSION ST., SUITE 100 San Marino, CA 91108
• Product Code: MWI
• CFR Regulation Number: 870.2300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-03-18
• Decision Date: 2015-05-15

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B299780LICCOP0	K150691	000
B299760MP0	K150691	000
B299760MIP0	K150691	000
B299760MICP0	K150691	000
B299760MIC0	K150691	000
B299760MI0	K150691	000
B299760MCP0	K150691	000
B299760MC0	K150691	000
B299760M0	K150691	000
B299760LP0	K150691	000
B299760LIP0	K150691	000
B299760LICP0	K150691	000
B299760N0	K150691	000
B299760NC0	K150691	000
B299760NCP0	K150691	000
B299780LICCO0	K150691	000
B299780LIC0	K150691	000
B299780LI0	K150691	000
B299780LCP0	K150691	000
B299780LC0	K150691	000
B299780L0	K150691	000
B299760NP0	K150691	000
B299760NIP0	K150691	000
B299760NICP0	K150691	000
B299760NIC0	K150691	000
B299760NI0	K150691	000
B299760LIC0	K150691	000
B299760LI0	K150691	000
B299760LCP0	K150691	000
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B299750MCP0	K150691	000
B299750MC0	K150691	000
B299750M0	K150691	000
B299750LP0	K150691	000
B299750LIP0	K150691	000
B299750LICP0	K150691	000
B299750LIC0	K150691	000
B299750LI0	K150691	000
B299750LCP0	K150691	000
B299750LC0	K150691	000
B299750MIC0	K150691	000
B299750MICP0	K150691	000
B299750MIP0	K150691	000
B299760LC0	K150691	000
B299760L0	K150691	000
B299750NP0	K150691	000
B299750NIP0	K150691	000
B299750NICP0	K150691	000
B299750NIC0	K150691	000
B299750NI0	K150691	000
B299750NCP0	K150691	000
B299750NC0	K150691	000
B299750N0	K150691	000
B299750MP0	K150691	000
B299750L0	K150691	000
B299780NPMP0	K150691	000
B299780NIC0	K150691	000
B299780NI0	K150691	000
B299780NCP0	K150691	000
B299780NCO0	K150691	000
B299780NC0	K150691	000
B299780N0	K150691	000
B299780MPMP0	K150691	000
B299780MPMO2P0	K150691	000
B299780MPMO20	K150691	000
B299780MPM0	K150691	000
B299780MP0	K150691	000
B299780NICCO0	K150691	000
B299780NICCOP0	K150691	000
B299780NICO0	K150691	000
B299780NPMO2P0	K150691	000
B299780NPMO20	K150691	000
B299780NPM0	K150691	000
B299780NP0	K150691	000
B299780NIPMP0	K150691	000
B299780NIPMO2P0	K150691	000
B299780NIPMO20	K150691	000
B299780NIPM0	K150691	000
B299780NIP0	K150691	000
B299780NICP0	K150691	000
B299780NICOP0	K150691	000
B299780MIPMP0	K150691	000
B299780MIPMO2P0	K150691	000
B299780MIPMO20	K150691	000
B299780LPMO20	K150691	000
B299780LPM0	K150691	000
B299780LP0	K150691	000
B299780LIPMP0	K150691	000
B299780LIPMO2P0	K150691	000
B299780LIPMO20	K150691	000
B299780LIPM0	K150691	000
B299780LIP0	K150691	000
B299780LICP0	K150691	000
B299780LICOPMO20	K150691	000
B299780LICOP0	K150691	000
B299780LPMO2P0	K150691	000
B299780LPMP0	K150691	000
B299780M0	K150691	000
B299780MIPM0	K150691	000
B299780MIP0	K150691	000
B299780MICP0	K150691	000
B299780MICOP0	K150691	000
B299780MICO0	K150691	000
B299780MICCOP0	K150691	000
B299780MICCO0	K150691	000
B299780MIC0	K150691	000
B299780MI0	K150691	000
B299780MCP0	K150691	000
B299780MC0	K150691	000
B299780LICO0	K150691	000