MASIMO LNCS/M-LNCS OXIMETRY SENSORS

Oximeter

MASIMO CORPORATION

The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Masimo Lncs/m-lncs Oximetry Sensors.

Pre-market Notification Details

• Device ID: K101896
• 510k Number: K101896
• Device Name: MASIMO LNCS/M-LNCS OXIMETRY SENSORS
• Classification: Oximeter
• Applicant: MASIMO CORPORATION 40 PARKER Irvine, CA 92618
• Contact: Marguerite Thomlinson
• Correspondent: Marguerite Thomlinson; MASIMO CORPORATION 40 PARKER Irvine, CA 92618
• Product Code: DQA
• CFR Regulation Number: 870.2700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-07-07
• Decision Date: 2010-10-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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