Oximeter

Product Code: DQA

Cardiovascular General Optical Products / Medical

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

Code of Federal Regulations: 870.2700


Radiation TypeOptical
Radition SafetyNone
Annual ReportsNo

Products Classified as DQA

209OximeterOximeter.

Total Product Life Cycle (TPLC) Devices

209OximeterOximeter.

FDA Consensus Standards

Oximeter [31334]21 CFR §870.2700 🔎
Oximeter [37508]21 CFR §870.2700 🔎
Oximeter [37929]21 CFR §870.2700 🔎

Pre-market Notifications for DQA

K221953Masimo CARESCAPE SpO2 – Masimo With SpHbMasimo Corporation
K221282Empatica Health Monitoring PlatformEmpatica S.r.l.
K220351Polso WatchChronisense Medical, Ltd.
K213515WesperO2Wesper Inc.
K212876Carescape SpO2 - MasimoMasimo Corporation
K212752Med-link Pulse OximeterShenzhen Med-link Electronics Tech Co., Ltd.
K212665Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911)Huizhou Xiaoou Technology Co., Ltd.
K212555Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHCCovidien Llc
K212300Pulse OximeterShenzhen Mericonn Technology Co., Ltd.
K212153Biobeat Platform, BB-613WP PatchBioBeat Technologies Ltd.
K211632Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104)Shenzhen Narig Bio-Medical Technology Co., Ltd.
K211407Belun Ring BLR-100XBelun Technology Company Limited
K211400Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.
K210305Pulse OximeterDongguan Lingxin Technologies Co., LTD
K210274Fingertip Pulse OximeterZhuhai Linte Medical Instrument Co., Ltd.

Global Unique Device Identification Database

00606959022843Oximeter
00606959022836Oximeter
00606959022812Oximeter
00606959022799Oximeter
00606959022768Oximeter
00606959022751Oximeter
00606959022744Oximeter
00606959022720Oximeter
00606959022690Oximeter
00606959022669Oximeter
00606959005150Oximeter
00370393908017Oximeter
10304040001339Oximeter
00260720011902Oximeter
00606959052369Oximeter

Maude Adverse Events

RAD-8, HORIZONTALMASIMO - 52 DISCOVERY2020-03-24
NELLCORNELLCOR PURITAN BENNETT MEXICO SA2020-03-20
RADICAL-7 HANDHELDMASIMO - 52 DISCOVERY2020-03-19
RADICAL-7 HANDHELDMASIMO - 52 DISCOVERY2020-03-18
RADICAL-7 HANDHELDMASIMO - 52 DISCOVERY2020-03-18
NELLCORMEDIANA CO. LTD.2020-03-18
NELLCORNELLCOR PURITAN BENNETT MEXICO SA2020-03-16
RADICAL-7 HANDHELDMASIMO - 52 DISCOVERY2020-03-14
RADICAL-7 HANDHELDMASIMO - 52 DISCOVERY2020-03-14
RADICAL-7 HANDHELDMASIMO - 52 DISCOVERY2020-03-14
RAD-5 PULSE OXIMETERMASIMO - 52 DISCOVERY2020-03-14
NELLCORMEDIANA CO. LTD.2020-03-13
RAINBOW SET PULSE CO-OXIMETRY CABLE, GE CARESCAPEMASIMO - 52 DISCOVERY2020-03-12
MASIMO RADICAL-7MASIMO CORPORATION2020-03-12
MASIMO RADICAL-7MASIMO CORPORATION2020-03-12
NELLCORMEDIANA CO. LTD.2020-03-10
NELLCORMEDIANA CO. LTD.2020-03-10
NELLCORMEDIANA CO. LTD.2020-03-10
NELLCORMEDIANA CO. LTD.2020-03-10
RADICAL-7 HANDHELDMASIMO - 52 DISCOVERY2020-03-05
NELLCORNELLCOR PURITAN BENNETT MEXICO SA2020-03-05
NELLCORCOVIDIEN AG NELLCOR2020-03-05
NELLCORMEDIANA CO. LTD.2020-03-03
NELLCORMEDIANA CO. LTD.2020-03-02
RD SET NEOMASIMO - 52 DISCOVERY2020-03-02
NELLCORMEDIANA CO. LTD.2020-02-28
NELLCORMEDIANA CO. LTD.2020-02-26
NELLCORMEDIANA CO. LTD.2020-02-26
NELLCORMEDIANA CO. LTD.2020-02-26
NELLCORNELLCOR PURITAN BENNETT MEXICO SA2020-02-26
NELLCORMEDIANA CO. LTD.2020-02-24
NELLCORNELLCOR PURITAN BENNETT IRELAND2020-02-24
NELLCORMEDIANA CO. LTD.2020-02-21
RD SET DCIMASIMO - 52 DISCOVERY2020-02-21
RD SET DCIMASIMO - 52 DISCOVERY2020-02-21
RADICAL-7 HANDHELDMASIMO - 52 DISCOVERY2020-02-21
RD SET DBIMASIMO - 52 DISCOVERY2020-02-21
RD SET MP - 05MASIMO - 52 DISCOVERY2020-02-21
RAD-8, HORIZONTALMASIMO - 52 DISCOVERY2020-02-20
RAD-8, HORIZONTALMASIMO - 52 DISCOVERY2020-02-20
NELLCORNELLCOR PURITAN BENNETT MEXICO SA2020-02-20
NASAL ALAR SP02 SENSORXHALE ASSURANCE, INC.2020-02-20
RD SET DCIMASIMO - 52 DISCOVERY2020-02-17
RD SET DCIMASIMO - 52 DISCOVERY2020-02-17
RAD-57 CONFIGURABLE PULSE CO-OXIMETERMASIMO - 52 DISCOVERY2020-02-14
KIT, RADIUS-7MASIMO - 52 DISCOVERY2020-02-14
RADICAL-7 HANDHELDMASIMO - 52 DISCOVERY2020-02-14
NONIN WRISTOX2 PULSE OXIMETERNONIN MEDICAL, INC.2020-02-14
RADIUS-7MASIMO CORPORATION2020-02-12
RADICAL-7 HANDHELDMASIMO - 52 DISCOVERY2020-02-11

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