Product Code: FLS


Products Classified as FLS

125Monitor, Apnea, Facility UseApnea Monitor.

Total Product Life Cycle (TPLC) Devices

125Monitor, Apnea, Facility UseApnea Monitor.

FDA Consensus Standards

Monitor, Apnea, Facility Use [32288]21 CFR §868.2377 🔎
Monitor, Apnea, Facility Use [32288]21 CFR §868.2377 🔎
Monitor, Apnea, Facility Use [32288]21 CFR §868.2377 🔎
Monitor, Apnea, Facility Use [32288]21 CFR §868.2377 🔎
Monitor, Apnea, Facility Use [32288]21 CFR §868.2377 🔎
Monitor, Apnea, Facility Use [32288]21 CFR §868.2377 🔎
Monitor, Apnea, Facility Use [32288]21 CFR §868.2377 🔎
Monitor, Apnea, Facility Use [32288]21 CFR §868.2377 🔎
Monitor, Apnea, Facility Use [32288]21 CFR §868.2377 🔎
Monitor, Apnea, Facility Use [32288]21 CFR §868.2377 🔎
Monitor, Apnea, Facility Use [32288]21 CFR §868.2377 🔎
Monitor, Apnea, Facility Use [32288]21 CFR §868.2377 🔎

Pre-market Notifications for FLS

K011597SMARTMONITOR 2, MODEL 4000RESPIRONICS GEORGIA, INC.
K991087HANNAH WIRELESS VITAL SIGNS MONITORILIFE SYSTEMS, INC.
K962865REMBRANDT SYSTEMAIRSEP CORP.
K951246PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONSPROTOCOL SYSTEMS, INC.
K894973RESPITRACE PLUSHOGAN & HARTSON
K832999RESPIRATION MONITORLITTON MEDICAL ELECTRONICS
K830778MONITORING KIT AMK-1ALTERNATIVE DESIGN SYSTEMS, INC.
K822077RESPIRATION MONITOR TYPE MR-10NEW DIMENSIONS IN MEDICINE, INC.
K821721CLINICAL DATA APNEA DETECTORCLINICAL DATA, INC.
K810153VENTILATORY EFFORT MONITORMEDICON, INC.
K802710INFANT APNEA MONITORDOUGLAS SCIENTIFIC PRODUCTS
K800164413A NEONATAL MONITORXEROX CORP.
K781216INFUSION CONTROLLER, PARENTERALNATIONAL PATENT DEVELOPMENT CORP.
K760635MEDI-DYNE APNEA MONITORMED DYNE INST., INC.
K760104RESPIRATION MONITORAIR-SHIELDS, INC.

Global Unique Device Identification Database

B0364003Monitor, Apnea, Facility Use
B0364002Monitor, Apnea, Facility Use

Maude Adverse Events

SMARTMONITOR 2CIRCADIANCE LLC2019-04-24
SMART MONITOR 2CIRCADIANCE, LLC2018-11-26
SMART MONITOR 2CIRCADIANCE2018-08-30
SMART MONITOR 2CIRCADIANCE, LLC2018-08-29
SMART MONITOR 2CIRCADIANCE, LLC2018-05-04
SMART MONITOR 2CIRCADIANCE LLC2016-08-12
SMART MONITOR 2CIRCADIANCE LLC.2016-07-06
SMARTMONITOR 2CIRCADIANCE, LLC.2016-03-29
SMARTMONITOR 2 W/O MODEMCIRCADIANCE, LLC2015-12-10
SMARTMONITOR 2 W/ MODEMCIRCADIANCE, LLC2015-12-03
SMARTMONITOR 2 WITH MODEMCIRCADIANCE LLC2015-09-30
SMARTMONITOR 2CIRCADIANCE LLC2015-08-11
SMARTMONITOR 2 WITH PCMCIA CARD SLOT AND INTERNAL MODEMPHILIPS MEDICAL SYSTEMS2015-06-25
SMARTMONITOR 2 WITH PCMCIA CARD SLOT AND INTERNAL MODEMPHILIPS MEDICAL SYSTEMS2015-06-12
SMARTMONITOR 2 WITH PCMCIA CARD SLOTPHILIPS MEDICAL SYSTEMS2015-05-27
SMARTMONITOR 2 WITH PCMCIA CARD SLOT AND INTERNAL MODEMPHILIPS MEDICAL SYSTEMS2015-04-30
SMARTMONITOR 2 WITH PCMCIA CARD SLOT AND INTERNAL MODEMPHILIPS MEDICAL SYSTEMS2015-04-08
SMARTMONITOR 2 WITH PCMCIA CARD SLOTPHILIPS MEDICAL SYSTEMS2015-03-23
SMARTMONITOR 2 WITH PCMCIA CARD SLOTPHILIPS MEDICAL SYSTEMS2015-03-06
SMARTMONITOR 2 WITH PCMCIA CARD SLOT AND INTERNAL MODEMPHILIPS MEDICAL SYSTEMS2015-02-20
SMARTMONITOR 2 PSRESPIRONICS, INC.2014-06-25
SMARTMONITOR 2 PSRESPIRONICS, INC.2014-06-25
SMARTMONITOR 2 PSRESPIRONICS, INC.2014-06-25
SMARTMONITOR 2 PSRESPIRONICS, INC.2014-06-25
SMARTMONITOR 2 PSRESPIRONICS, INC.2014-06-25
SMARTMONITOR 2 PSRESPIRONICS, INC.2014-06-25
SMARTMONITOR 2PHILIPS RESPIRONICS - CHMV2014-04-09
SMARTMONITOR 2PHILIPS RESPIRONICS - CHMV2014-04-04
SMART MONITOR 2 PSPHILIPS RESPIRONICS -CHMV2014-04-04
SMARTMONITOR 2PHILIPS RESPIRONICS -CHMV2014-03-07
SMARTMONITOR 2PHILLIPS RESPIRONICS - CHMV2014-02-21
SMARTMONITOR 2PHILLIPS RESPIRONICS - CHMV2014-02-21
SMARTMONITORPHILLIPS RESPIRONICS - CHMV2014-02-21
SMARTMONITOR 2 PSPHILLIPS RESPIRONICS - CHMV2014-02-21
SMARTMONITOR 2PHILIPS RESPIRONICS - CHMV2014-01-29
SMARTMONITOR 2PHILIPS RESPIRONICS - CHMV2013-12-23
SMARTMONITOR 2PHILLIPS RESPIRONICS - CHMV2013-11-06
SMARTMONITOR 2PHILIPS RESPIRONICS - CHMV2013-10-25
SMARTMONITOR 2PHILIPS RESPIRONICS - CHMV2013-09-27
SMARTMONITOR 2PHILIPS RESPIRONICS-CHMV2013-09-20
SMARTMONITOR 2 PROFESSIONAL SERIES MONITORPHILIPS RESPIRONICS - CHMV2013-08-29
SMARTMONITOR 2 PROFESSIONAL SERIESPHILIPS RESPIRONICS - CHMV2013-08-29
SMARTMONITOR 2 PROFESSIONAL SERIESPHILIPS RESPIRONICS - CHMV2013-08-23
SMARTMONITOR 2PHILIPS RESPIRONICS - CHMV2013-07-19
SMARTMONITOR 2PHILIPS RESPIRONICS - CHMV2013-07-02
SMARTMONITOR 2 WITH PCMCIA CARD SLOT AND INTERNAL MODEMPHILIPS RESPIRONICS - CHMV2013-05-30
SMARTMONITOR 2PHILIPS RESPIRONICS - CHMV2013-05-17
SMART MONITORCHILDRENS MEDICAL VENTURES LLC2013-04-12
SMART MONITOR2CHILDRENS MEDICAL VENTURES LLC2013-04-05
SMARTMONITOR 2CHILDRENS MEDICAL VENTURES , PHILIPS HEALTHCARE2013-03-20
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