MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER, MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER

Oximeter

MASIMO CORPORATION

The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Masimo Rainbow Set Radical 7 Pulse Co-oximeter, Masimo Rainbow Set Rad 87 Pulse Co-oximeter.

Pre-market Notification Details

• Device ID: K080238
• 510k Number: K080238
• Device Name: MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER, MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER
• Classification: Oximeter
• Applicant: MASIMO CORPORATION 40 PARKER Irvine, CA 92618
• Contact: Marquerite Thomlinson
• Correspondent: Marquerite Thomlinson; MASIMO CORPORATION 40 PARKER Irvine, CA 92618
• Product Code: DQA
• Subsequent Product Code: DPZ
• Subsequent Product Code: JKS
• CFR Regulation Number: 870.2700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-01-31
• Decision Date: 2008-05-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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