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 Type: Optical
• Radition Safety: None
• Annual Reports: No

Products Classified as DQA

209

Oximeter

Oximeter.

Total Product Life Cycle (TPLC) Devices

209

Oximeter

Oximeter.

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

K221953	Masimo CARESCAPE SpO2 – Masimo With SpHb	Masimo Corporation
K221282	Empatica Health Monitoring Platform	Empatica S.r.l.
K220351	Polso Watch	Chronisense Medical, Ltd.
K213515	WesperO2	Wesper Inc.
K212876	Carescape SpO2 - Masimo	Masimo Corporation
K212752	Med-link Pulse Oximeter	Shenzhen Med-link Electronics Tech Co., Ltd.
K212665	Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911)	Huizhou Xiaoou Technology Co., Ltd.
K212555	Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC	Covidien Llc
K212300	Pulse Oximeter	Shenzhen Mericonn Technology Co., Ltd.
K212153	Biobeat Platform, BB-613WP Patch	BioBeat Technologies Ltd.
K211632	Pulse 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.
K211407	Belun Ring BLR-100X	Belun Technology Company Limited
K211400	Pulse Oximeter	Beijing Choice Electronic Technology Co., Ltd.
K210305	Pulse Oximeter	Dongguan Lingxin Technologies Co., LTD
K210274	Fingertip Pulse Oximeter	Zhuhai Linte Medical Instrument Co., Ltd.

Global Unique Device Identification Database

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

Maude Adverse Events

RAD-8, HORIZONTAL	MASIMO - 52 DISCOVERY	2020-03-24
NELLCOR	NELLCOR PURITAN BENNETT MEXICO SA	2020-03-20
RADICAL-7 HANDHELD	MASIMO - 52 DISCOVERY	2020-03-19
RADICAL-7 HANDHELD	MASIMO - 52 DISCOVERY	2020-03-18
RADICAL-7 HANDHELD	MASIMO - 52 DISCOVERY	2020-03-18
NELLCOR	MEDIANA CO. LTD.	2020-03-18
NELLCOR	NELLCOR PURITAN BENNETT MEXICO SA	2020-03-16
RADICAL-7 HANDHELD	MASIMO - 52 DISCOVERY	2020-03-14
RADICAL-7 HANDHELD	MASIMO - 52 DISCOVERY	2020-03-14
RADICAL-7 HANDHELD	MASIMO - 52 DISCOVERY	2020-03-14
RAD-5 PULSE OXIMETER	MASIMO - 52 DISCOVERY	2020-03-14
NELLCOR	MEDIANA CO. LTD.	2020-03-13
RAINBOW SET PULSE CO-OXIMETRY CABLE, GE CARESCAPE	MASIMO - 52 DISCOVERY	2020-03-12
MASIMO RADICAL-7	MASIMO CORPORATION	2020-03-12
MASIMO RADICAL-7	MASIMO CORPORATION	2020-03-12
NELLCOR	MEDIANA CO. LTD.	2020-03-10
NELLCOR	MEDIANA CO. LTD.	2020-03-10
NELLCOR	MEDIANA CO. LTD.	2020-03-10
NELLCOR	MEDIANA CO. LTD.	2020-03-10
RADICAL-7 HANDHELD	MASIMO - 52 DISCOVERY	2020-03-05
NELLCOR	NELLCOR PURITAN BENNETT MEXICO SA	2020-03-05
NELLCOR	COVIDIEN AG NELLCOR	2020-03-05
NELLCOR	MEDIANA CO. LTD.	2020-03-03
NELLCOR	MEDIANA CO. LTD.	2020-03-02
RD SET NEO	MASIMO - 52 DISCOVERY	2020-03-02
NELLCOR	MEDIANA CO. LTD.	2020-02-28
NELLCOR	MEDIANA CO. LTD.	2020-02-26
NELLCOR	MEDIANA CO. LTD.	2020-02-26
NELLCOR	MEDIANA CO. LTD.	2020-02-26
NELLCOR	NELLCOR PURITAN BENNETT MEXICO SA	2020-02-26
NELLCOR	MEDIANA CO. LTD.	2020-02-24
NELLCOR	NELLCOR PURITAN BENNETT IRELAND	2020-02-24
NELLCOR	MEDIANA CO. LTD.	2020-02-21
RD SET DCI	MASIMO - 52 DISCOVERY	2020-02-21
RD SET DCI	MASIMO - 52 DISCOVERY	2020-02-21
RADICAL-7 HANDHELD	MASIMO - 52 DISCOVERY	2020-02-21
RD SET DBI	MASIMO - 52 DISCOVERY	2020-02-21
RD SET MP - 05	MASIMO - 52 DISCOVERY	2020-02-21
RAD-8, HORIZONTAL	MASIMO - 52 DISCOVERY	2020-02-20
RAD-8, HORIZONTAL	MASIMO - 52 DISCOVERY	2020-02-20
NELLCOR	NELLCOR PURITAN BENNETT MEXICO SA	2020-02-20
NASAL ALAR SP02 SENSOR	XHALE ASSURANCE, INC.	2020-02-20
RD SET DCI	MASIMO - 52 DISCOVERY	2020-02-17
RD SET DCI	MASIMO - 52 DISCOVERY	2020-02-17
RAD-57 CONFIGURABLE PULSE CO-OXIMETER	MASIMO - 52 DISCOVERY	2020-02-14
KIT, RADIUS-7	MASIMO - 52 DISCOVERY	2020-02-14
RADICAL-7 HANDHELD	MASIMO - 52 DISCOVERY	2020-02-14
NONIN WRISTOX2 PULSE OXIMETER	NONIN MEDICAL, INC.	2020-02-14
RADIUS-7	MASIMO CORPORATION	2020-02-12
RADICAL-7 HANDHELD	MASIMO - 52 DISCOVERY	2020-02-11