Oximeter, Ear

Product Code: DPZ

Cardiovascular General Optical Products / Medical

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 870.2710


Radiation TypeOptical
Radition SafetyNone
Annual ReportsNo

Products Classified as DPZ

208Oximeter, EarEar Oximeter.

Total Product Life Cycle (TPLC) Devices

208Oximeter, EarEar Oximeter.

FDA Consensus Standards

Oximeter, Ear [31334]21 CFR §870.2710 🔎

Pre-market Notifications for DPZ

K042675FLEXI-STAT SP02 EAR SENSORELEKON INDUSTRIES U.S.A., INC.
K040831DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500DATEX-OHMEDA, INC.
K012333FLEXI-SITE SP02 EAR SENSOREPIC MEDICAL EQUIPMENT SERVICES, INC.
K010718FLEXI-SITE SP02 EAR SENSOREPIC MEDICAL EQUIPMENT SERVICES, INC.
K944760DURA-Y OXYGEN TRANSDUCER, EAR CLIPNELLCOR, INC.
K942752MARQUETTE EAR PROBE SENSORMARQUETTE ELECTRONICS, INC.
K862426PULSE OXIMETERDRAEGER MEDICAL, INC.
K845051VITALOG PMS-8VITALOG CORP.
K810363EAR OXIMETERBIO-TEK INSTRUMENTS, INC.

Global Unique Device Identification Database

00843997003230Oximeter, ear
00843997001540Oximeter, ear
00843997000239Oximeter, ear
00843997000048Oximeter, ear
07640121880773Oximeter, Ear
07640121880759Oximeter, Ear
07640121880742Oximeter, Ear
07640121880568Oximeter, Ear
07640121880513Oximeter, Ear
07640121880506Oximeter, Ear
07640121880490Oximeter, Ear
07640121880445Oximeter, Ear
07640121880438Oximeter, Ear
07640121880308Oximeter, Ear
07640121880230Oximeter, Ear

Maude Adverse Events

TOSCA SENSOR 92RADIOMETER BASEL AG2019-06-26
M-LNCS TC-IMASIMO - 40 PARKER2019-06-12
RD SET TC-IMASIMO - 40 PARKER2018-12-20
RD SET TC-IMASIMO - 40 PARKER2018-07-06
SENTEC V-SIGNIMAGENIX, INC2018-04-27
TRUSATCRITIKON DE MEXICO S. DE R.L. DE C.V.2017-09-06
RAD-8MASIMO - 40 PARKER2017-05-04
NSATXGE HEALTHCARE2017-03-24
OXIMETERGE HEALTHCARE2017-03-24
NELLCORCOVIDIEN2016-11-29
MASIMO SET REUSABLE FOREHEAD SENSOR (TFA)MASIMO CORPORATION2016-09-21
NELLCOR, INC.COVIDIEN2016-05-24
NELLCORCOVIDIEN2016-04-21
NELLCORNELLCOR2016-04-05
TOSCA 500 USA2015-09-08
OXIMAXCOVIDIEN2015-03-09
OXIMAXCOVIDIEN2015-03-03
PULSE OXIMETER - OXIMAXCOVIDIEN2015-03-02
DURA-Y SENSORCOVIDIEN2015-02-20
OXIMAX N-595 PULSE OXIMETERCOVIDIEN2015-02-06
OXIMAX N-560 PULSE OXIMETERMEDIANA2014-11-24
OXIMAX N-560 PULSE OXIMETERMEDIANA2014-11-24
DURA-Y SENSORCOVIDIEN2014-11-05
OXIMAX N-595 PULSE OXIMETERCOVIDIEN2014-08-07
OXIMAX N-595 PULSE OXIMETERCOVIDIEN2014-08-07
OXIMAX N-560 PULSE OXIMETERMEDIANA2014-07-25
OXIMAX N-595 PULSE OXIMETERCOVIDIEN2014-06-26
OXIMAX N-595 PULSE OXIMETERCOVIDIEN2014-06-26
OXIMAX N-560 PULSE OXIMETERMEDIANA2014-06-25
OXIMETER N-560 PULSE OXIMETERMEDIANA2014-06-18
OXIMAX N-560 PULSE OXIMETERMEDIANA2014-06-18
OXIMAX N-560 PULSE OXIMETERMEDIANA2014-05-30
OXIMAX N-560 PULUSE OXIMETERMEDIANA2014-05-30
SENSOR, NEONATE LNCSMASIMO CORPORATION2014-05-29
OXIMAX N-560 PULSE OXIMETERMEDIANA2014-05-05
OXIMAX N-560 PULSE OXIMETERMEDIANA2014-04-30
OXIMAX N-560 PULSE OXIMETERMEDIANA2014-04-30
OXIMAX N-560 PULSE OXIMETERMEDIANA2014-04-29
OXIMAX N-560 PULSE OXIMETERMEDIANA2014-04-25
OXIMAX N-560 PULSE OXIMETERMEDIANA2014-04-25
OXIMAX N-560 PULSE OXIMETERMEDIANA2014-04-21
OXIMAX N-560 PULSE OXIMETERMEDIANA2014-04-15
OXIMAX N-560 PULSE OXIMETERMEDIANA2014-04-08
OXIMAX N-560 PULSE OXIMETERMEDIANA2014-04-08
OXIMAX N-560 PULSE OXIMETERMEDIANA2014-03-28
OXIMAX N-595 PULSE OXIMETERCOVIDIEN2014-03-28
OXIMAX DS100A DURASENSORCOVIDIEN2014-03-27
OXIMAX N-560 PULSE OXIMETERMEDIANA2014-03-27
OXIMAX N-560 PULSE OXIMETERMEDIANA2014-03-25
OXIMAX N-560 PULSE OXIMETERMEDIANA2014-03-21

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.