MEDWAND SOLUTIONS, INC

FDA Device Registration & Listing · RSM, CA, US · Registration 3024491912

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
3024491912
FEI Number
3024491912
Entity Name
MEDWAND SOLUTIONS, INC
City/State/Country
RSM, CA, US
Establishment Address
23162 Arroyo Vista, RSM, CA 92688, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
MedWand Solutions, Inc (Owner Number: 10086016)
Owner / Operator Contact Address
23162 Arroyo Vista, Rancho Santa Margarita, CA 92688, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K212975
PMA Number
N/A

All Registered Proprietary Names

MedWand (tm) Device

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQA Oximeter Cardiovascular Class 2 870.2700 2022-10-10
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2022-10-10
DQD Stethoscope, Electronic Cardiovascular Class 2 870.1875 2022-10-10
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2022-10-10

Official Correspondent

Danforth Lincoln

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MedWand Solutions, 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

Similar Registrations

Registration Number Establishment Name Location
3014652024 CEA GROUP INTERNATIONAL CO.,LTD Wenzhou Zhejiang, CN
1062836 DIGICARE BIOMEDICAL TECHNOLOGY, INC. BOYNTON BEACH, FL, US
3013250653 MASIMO CORPORATION Irvine, CA, US
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 3024491912. Last updated year: 2026. Please use registration number 3024491912 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.