Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011353016

FEI Number

3011353016

Entity Name

HUNAN ACCURATE BIO-MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Changsha Hunan, CN

Establishment Address

Accurate Industrial Park, No.108, Zhixian Road, Xuelian Community, Xueshi Street of Yuelu District, Changsha Hunan 410208, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Hunan Accurate Bio-Medical Technology Co., Ltd. (Owner Number: 10048204)

Owner / Operator Contact Address

Accurate Industrial Park, No.108, Zhixian Road, Xuelian Community, Xueshi Street of Yuelu District, Changsha, CN-HN 410208, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pulse oximeter HS10A Pulse oximeter (model: FS20F1) Pulse oximeter(model:FS20C,FS20D,FS20E,FS20F,FS20I,FS20K,FS20M,FS20L,FS20P,HS10A,HS20A) Pulse oximeter(model:WS20A,WS20B,FS10C,FS10D,FS10E,FS10F,FS10I,FS10K,FS10M,FS10L) Pulse Oximeter (model: WS20A, WS20E) Pulse Oximeter; Pulse Oximeter FS10C and FS20C; Pulse Oximeter FS10D and FS20D Pulse Oximeter FS10E and FS20E Pulse Oximeter FS10F and FS20F;Pulse Oximeter FS10I;Pulse Oximeter FS10K and FS20K;Pulse Oximeter FS10P; Pulse Oximeter (model: FS20P, FS10L, FS20L, FS10M, FS20M, FS20I) NASAL IRRIGATOR (model: NS1A3, NS2A3, NS3A3, NS1C3, NS2C3, NS3C3, NS1D3) Nasal Irrigator (model: NH2A1, NH2A3, NH3A5, NH2B3, NH2C3, NH2D3, NH2D4, NH2E3, NH2F3, NH2G3) Pulse oximeter FS10A,FS20A,FS10C,FS20C,FS10D,FS20D,FS10E,FS20E,HS10A,HS20A, Pulse Oximeter FS10F and FS20F;Pulse Oximeter FS10I;Pulse Oximeter FS10K and FS20K;Pulse Oximeter FS10P; Handheld Pulse Oximeter (model: HS20A) Pulse Oximeter FS10B and FS20B Concord Fingertip Pulse Oximeter (model: 75079); Concord Handheld Pulse Oximeter (model: 75023) Handheld Pulse Oximeter-Rechargeable (model: 75023R) Pulse oximeter(model:FS20P) Pulse Oximeter (WS20A), Pulse Oximeter (WS10A) Concord Wrist Oximeter (model: 75044,75044B) Pelvic Floor Exerciser (model: PF01, PF02, PF03)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2018-04-10
PGJ	Oximeter, Wellness	Cardiovascular	Class 2	870.2700	2021-07-09
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-12-20
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2014-12-16
KMA	Irrigator, Powered Nasal	Ear, Nose, Throat	Class 1	874.5550	2023-03-07
OCH	Oximeter, Infrared, Sporting, Aviation	Cardiovascular	Class 2	870.2700	2015-01-04
KXQ	Vibrator For Therapeutic Use, Genital	Obstetrics/Gynecology	Class 2	884.5960	2025-07-14

Official Correspondent

Li Zhang

US Agent Details

Linda Chen Business: Dynasty Medical Consulting Inc. Email: usagent@chonconn.com Phone: (832) 3809688

Related Public Records

Same Entity

Hunan Accurate Bio-Medical Technology Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K903523	Hewlett-Packard Co.	HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE	1990-10-23
K973147	Nellcor Puritan Bennett, Inc.	NPB-295 PULSE OXIMETER	1997-11-14
K231243	Guangdong Genial Technology Co., Ltd.	Finger Clip Pulse Oximeter	2023-10-31
K971628	Somanetics Corp.	SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)	1997-10-10
K153184	Shenzhen Caremed Medical Technology Co., Ltd.	Caremed Reusable & Disposable SPO2 Sensors	2017-01-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M, Part Number CS08653
Z-0029-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M W/PRINTER, Part Number CS08659

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3013418500	Quintana Supply, a division of Thomas Scientific	Haverhill, MA, US
9614470	RADIOMETER BASEL AG	BASEL Basel-Stadt, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011353016. Last updated year: 2026. Please use registration number 3011353016 when referencing this establishment in official correspondence.