Medical Device Manufacturer · US , Irvine , CA

Masimo Corp. - FDA 510(k) Cleared Devices

28 submissions · 28 cleared · Since 1997

Recent clearances: LNCS OXIMETRY SENSORS, NC SP02 ADAPTER CABLE, MASIMO SET INTELLIVUE PULSE OXIMETER MODULE

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28

Total

28

Cleared

0

Denied

FDA 510(k) Regulatory Record - Masimo Corp. Anesthesiology ✕

28 devices

1-12 of 28

Cleared Jul 29, 2004

LNCS OXIMETRY SENSORS

Anesthesiology · 23d

Cleared Jun 29, 2004

NC SP02 ADAPTER CABLE

Anesthesiology · 53d

Cleared Apr 22, 2004

MASIMO SET INTELLIVUE PULSE OXIMETER MODULE

Anesthesiology · 78d

Cleared Mar 19, 2004

MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V

Anesthesiology · 86d

Cleared Feb 25, 2004

MODIFICATION TO: MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP...

Anesthesiology · 26d

Cleared Feb 19, 2004

MASIMO LNOP-TF-I RESUABLE TRANSFLECTANCE SENSOR

Anesthesiology · 184d

Cleared Feb 19, 2004

MASIMO SET RAD-5 PULSE OXIMETER, MODEL RAD-5

Anesthesiology · 128d

Cleared Jan 28, 2004

AC-1 SP02 ADAPTOR CABLE, MODEL AC-1

Anesthesiology · 100d

Cleared Dec 12, 2003

SPO2.COM OXIMETRY SENSORS, MULTIPLE MODELS

Anesthesiology · 59d

Cleared May 12, 2003

MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP...

Anesthesiology · 14d

Cleared Dec 11, 2001

MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP...

Anesthesiology · 27d

Cleared Oct 03, 2001

MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND MASIMO SERIES OF SENSORS...

Anesthesiology · 27d