Buffalo Office

FDA Device Registration & Listing · Buffalo, NY, US · Registration 3038429306

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
3038429306
FEI Number
3038429306
Entity Name
Buffalo Office
City/State/Country
Buffalo, NY, US
Establishment Address
505 Ellicott St Ste 291, Buffalo, NY 14203, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
OxiWear Inc (Owner Number: 10092245)
Owner / Operator Contact Address
2231 Crystal Dr, Ste 204, Arlington, VA 22202, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K233827
PMA Number
N/A

All Registered Proprietary Names

OxiWear

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DPZ Oximeter, Ear Cardiovascular Class 2 870.2710 2024-12-17
DQA Oximeter Cardiovascular Class 2 870.2700 2024-12-17

Official Correspondent

Shavini Fernando

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OxiWear Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3026998289 OXIWEAR INC Arlington, VA, US

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 3038429306. Last updated year: 2026. Please use registration number 3038429306 when referencing this establishment in official correspondence.
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