AIDAR HEALTH, INC

FDA Device Registration & Listing · Columbia, MD, US · Registration 3023412068

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
3023412068
FEI Number
3023412068
Entity Name
AIDAR HEALTH, INC
City/State/Country
Columbia, MD, US
Establishment Address
7134 Columbia Gateway Dr Ste 150, Columbia, MD 21046, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
Aidar Health, Inc (Owner Number: 10086144)
Owner / Operator Contact Address
3402 Birch Hollow Rd, Pikesville, MD 21208, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K201635
PMA Number
N/A

All Registered Proprietary Names

Aidar Health MouthLab

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2022-10-18
DQA Oximeter Cardiovascular Class 2 870.2700 2022-10-18
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2022-10-18
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2022-10-18
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2022-10-18
BZH Meter, Peak Flow, Spirometry Anesthesiology Class 2 868.1860 2022-10-18
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2022-10-18

Official Correspondent

Sathya Elumalai

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Aidar Health, 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
K913749 Edentec Corp. EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170 1992-07-02
K771407 Research Development Corp. LUNG VOLUME & PRESSURE MONITOR 1977-08-04
K122223 Philips Medizin Systeme Boeblingen GmbH NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO 2013-04-12
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

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 3023412068. Last updated year: 2026. Please use registration number 3023412068 when referencing this establishment in official correspondence.
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