Medical Device Manufacturer · US , White Bear Lake , MN

Nonin Medical, Inc. - FDA 510(k) Cleared Devices

50 submissions · 50 cleared · Since 1986

Recent clearances: Nonin OTC Pulse Oximeter Model 3250, H500 Multi-Sensing Oximetry System, Pulse Oximeter

50

Total

50

Cleared

0

Denied

FDA 510(k) Regulatory Record - Nonin Medical, Inc. Cardiovascular ✕

5 devices

1-5 of 5

Cleared Aug 27, 2015

SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg,...

Cardiovascular · 101d

Cleared May 14, 2012

MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY

Cardiovascular · 195d

Cleared Dec 17, 2010

REGIONAL OXIMETER

Cardiovascular · 88d

Cleared Jun 30, 2009

REGIONAL OXIMETER SYSTEM, MODEL 7600

Cardiovascular · 97d

Cleared Mar 22, 2004

MODEL AVANT 2120 PULSE OXIMETER AND NIBP

Cardiovascular · 315d