FDA.reportPublic FDA data

FondCircle

Primary DI
00850070979153
Brand
FondCircle
Company
FondCircle Inc.
Model
FPO-F1
Device description
Pulse Oximeter
Published
2025-01-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232989000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232989000Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E)Shenzhen AOJ Medical Technology Co., Ltd.2024-07-01DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850070979153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850070979153008500709791538500709791530850070979153

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeterAn electrically-powered photoelectric device designed for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals are produced by light-emitting diodes (LEDs) and received by a photodetector. The device displays the SpO2 values and may also measure/display pulse rate. It is typically applied to the fingertip or around the wrist, may be single-component (with built-in probe) or multi-component (includes external probe), and may in addition wirelessly transmit measurements to a receiving location (e.g., central station, bedside monitor); it is intended to be operated by laypersons and healthcare providers.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
060715854
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850070979122FondCircleFBP-U12025-01-14
00850070979207FondCircleM1-SL502025-03-12
00850070979214FondCircleM1-SL1002025-03-12
00850070979184FondCircleM1-L502025-03-10
00850070979160FondCircleFTM-B12025-01-14
00850070979283FondCircleIK2025-04-06
00850070979290FondCircleM1-SL1002025-04-06
00850070979306FondCircleM1-SL502025-04-06
00850070979313FondCircleFBG-M12025-04-06
00850070979252FondCircleM1-S502025-03-18
00850070979221FondCircleM1-S252025-03-14
00850070979238FondCircleM12025-03-14
00850070979191FondCircleM1-S502025-02-26
00850070979047FondCircleFBG-M22025-01-14
00850070979054FondCircleFBG-M12025-01-14
00850070979061FondCircleFBF-F42025-01-14
00850070979078FondCircleFBF-F32025-01-14
00850070979085FondCircleFBF-F22025-01-14
00850070979092FondCircleFBF-F12025-01-14
00850070979108FondCircleFBF-W12025-01-14

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Primary DI, Brand, Company table
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10884521855403NellcorCovidien LPDQA2026-05-29
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B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
09551028900069Cables and SensorsXINMED SDN. BHD.DQA2026-04-22
06924054300586BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-04-22
08052990320318MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03