SOLARIS MEDICAL TECHNOLOGY, INC.

FDA Device Registration & Listing · Shenzhen Guangdong, CN · Registration 3006552505

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006552505
FEI Number
3006552505
Entity Name
SOLARIS MEDICAL TECHNOLOGY, INC.
City/State/Country
Shenzhen Guangdong, CN
Establishment Address
Zhongjian Industrial Building One #401, 18 Yanshan Road, Shekou, Nanshan District, Shenzhen Guangdong 518067, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Solaris Medical Technology, Inc. (Owner Number: 10025740)
Owner / Operator Contact Address
Zhongjian Industrial Building One #401, 18 Yanshan Rd, Shekou, Nanshan District, Shenzhen, CN-GD 518067, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K100077
PMA Number
N/A

All Registered Proprietary Names

SOLARIS SOLARIS SOLARIS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQA Oximeter Cardiovascular Class 2 870.2700 2008-05-05
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2011-01-03
DQA Oximeter Cardiovascular Class 2 870.2700 2011-01-03

Official Correspondent

Linda Yuan

US Agent Details

Rachel Cheng Business: Solaris Medical Technology, Inc. Email: rcheng@solarismedtech.com Phone: (415) 6663980

Related Public Records

Same Entity

Solaris Medical Technology, Inc.
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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006552505. Last updated year: 2026. Please use registration number 3006552505 when referencing this establishment in official correspondence.
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