CARDA HEALTH

FDA Device Registration & Listing · Houston, TX, US · Registration 3038878471

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
3038878471
FEI Number
3038878471
Entity Name
CARDA HEALTH
City/State/Country
Houston, TX, US
Establishment Address
10795 Hammerly Blvd Ste H11, Houston, TX 77043, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Carda Health (Owner Number: 10093463)
Owner / Operator Contact Address
8 The Grn, Suite 11670, Dover, DE 19901, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K242876
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQA Oximeter Cardiovascular Class 2 870.2700 2025-05-19
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-05-19
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-05-19
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-05-19
DQA Oximeter Cardiovascular Class 2 870.2700 2025-05-19

Official Correspondent

Jane Dong

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Carda Health
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
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038878471. Last updated year: 2026. Please use registration number 3038878471 when referencing this establishment in official correspondence.
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