Masimo Root Monitoring System And Accessories

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

Masimo Corporation

The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Masimo Root Monitoring System And Accessories.

Pre-market Notification Details

• Device ID: K171121
• 510k Number: K171121
• Device Name: Masimo Root Monitoring System And Accessories
• Classification: Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
• Applicant: Masimo Corporation 52 Discovery Irvine, CA 92618
• Contact: Marguerite Thomlinson
• Correspondent: Marguerite Thomlinson; Masimo Corporation 52 Discovery Irvine, CA 92618
• Product Code: MWI
• Subsequent Product Code: BZQ
• Subsequent Product Code: CAT
• Subsequent Product Code: CBQ
• Subsequent Product Code: CBR
• Subsequent Product Code: CBS
• Subsequent Product Code: CCK
• Subsequent Product Code: CCL
• Subsequent Product Code: DPZ
• Subsequent Product Code: DQA
• Subsequent Product Code: DXN
• Subsequent Product Code: FLL
• Subsequent Product Code: GWQ
• Subsequent Product Code: GXY
• Subsequent Product Code: NHO
• Subsequent Product Code: NHP
• Subsequent Product Code: NHQ
• Subsequent Product Code: OLT
• Subsequent Product Code: OLW
• Subsequent Product Code: OMC
• Subsequent Product Code: &nb
• CFR Regulation Number: 870.2300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-04-17
• Decision Date: 2017-11-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
17350046132259	K171121	000
17350046132624	K171121	000
17350046132617	K171121	000
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17350046131177	K171121	000
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07350046132115	K171121	000