Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033959233

FEI Number

3033959233

Entity Name

Jaeger Medical America Inc.

City/State/Country

Moreno Valley, CA, US

Establishment Address

14050 Rebecca St Bldg 4, Moreno Valley, CA 92553, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device

Owner / Operator

Jaeger Medical GmbH (Owner Number: 10092652)

Owner / Operator Contact Address

Leibnizstrasse 7, Hoechberg, DE-BY 97204, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Disposable Mouthpiece, Flex V-892894 Disposable Mouthpiece, plastic 892103 Disposable Mouthpiece, plastic V-892896 Disposable Mouthpiece, Flex V-892893 Disposable Mouthpiece, Flex V-892897 Gas Cylinder 706960 Pressure Regulator Nose clip reusable V-892895 Nose clip single patient use V-892900 Nose clip pad single patient use 892121 Vmax 229 Series Sentry WEB Smartinterp MasterScreen Pneumo APS Pro MasterScreen CPX & Oxycon CPX Vyntus / SentrySuite Product Line Vyntus ECG Vyntus CPX, Vyntus / SentrySuite Product Line Calibration Syringe V-720254-13 JQM Syringe V-720000-13 Vyntus WALK Vyntus SPIRO MasterScreen Pneumo Vyntus CPX / Vyntus ECG O2 Test Static and Dynamic Compliance for Vmax CO Test MasterScreen PFT Body MasterScreen IOS (JLAB 5.x) MicroGard II Filter Kit MicroGard II Filter MS CPX partially mobile N2O Test SentrySuite Product Line 2.7 SentrySuite Product Line 2.3 V-707377 USS Module

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2025-02-04
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2025-02-04
BXJ	Clip, Nose	Anesthesiology	Class 1	868.6225	2025-02-04
BTY	Calculator, Predicted Values, Pulmonary Function	Anesthesiology	Class 2	868.1890	2025-02-04
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2025-02-04
BZC	Calculator, Pulmonary Function Data	Anesthesiology	Class 2	868.1880	2025-02-04
BTY	Calculator, Predicted Values, Pulmonary Function	Anesthesiology	Class 2	868.1890	2025-02-04
BZC	Calculator, Pulmonary Function Data	Anesthesiology	Class 2	868.1880	2025-02-04
BZC	Calculator, Pulmonary Function Data	Anesthesiology	Class 2	868.1880	2025-02-04
BZC	Calculator, Pulmonary Function Data	Anesthesiology	Class 2	868.1880	2025-02-04
BZC	Calculator, Pulmonary Function Data	Anesthesiology	Class 2	868.1880	2025-02-04
BXW	Calibrator, Volume, Gas	Anesthesiology	Class 1	868.1870	2025-02-04
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2025-02-04
BTY	Calculator, Predicted Values, Pulmonary Function	Anesthesiology	Class 2	868.1890	2025-02-03
BZC	Calculator, Pulmonary Function Data	Anesthesiology	Class 2	868.1880	2025-02-03
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2025-02-03
MLC	Monitor, St Segment	Cardiovascular	Class 2	870.2340	2025-02-03
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2025-02-03
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2025-02-04
BTY	Calculator, Predicted Values, Pulmonary Function	Anesthesiology	Class 2	868.1890	2025-02-04
CCJ	Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase	Anesthesiology	Class 2	868.1430	2025-02-04
JEH	Plethysmograph, Volume	Anesthesiology	Class 2	868.1760	2025-02-04
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2025-02-04
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2025-02-03
BZC	Calculator, Pulmonary Function Data	Anesthesiology	Class 2	868.1880	2025-02-04
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2025-02-04
JEH	Plethysmograph, Volume	Anesthesiology	Class 2	868.1760	2025-02-03
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2025-02-03
BTY	Calculator, Predicted Values, Pulmonary Function	Anesthesiology	Class 2	868.1890	2025-02-03
BZC	Calculator, Pulmonary Function Data	Anesthesiology	Class 2	868.1880	2025-02-03
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2025-02-03
BZC	Calculator, Pulmonary Function Data	Anesthesiology	Class 2	868.1880	2025-02-03
BTY	Calculator, Predicted Values, Pulmonary Function	Anesthesiology	Class 2	868.1890	2025-02-03
BXP	Transducer, Gas Flow	Anesthesiology	Class 1	868.2885	2025-02-04

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Jaeger Medical GmbH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9615102	Jaeger Medical GmbH	HOECHBERG Bavaria, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K935043	Siemens Medical Electronics	SIEMENS CLINICAL WORK STATION	1995-04-07
K170948	Acutus Medical, Inc.	AcQMap High Resolution Imaging and Mapping System	2017-10-16
K242016	ABBOTT MEDICAL	EnSite X EP System	2024-08-09
K172182	St. Jude Medical (Now Part of the Abbott Medical)	QUANTIEN Measurement System	2017-08-18
K252013	ABBOTT MEDICAL	EnSite X EP System	2025-09-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0037-2010	Airgas Puritan Medical Puritan Medical Unit	1	AGI-2237 Portable 2 Cylinder Manifold Cart, for connecting medical gas cylinders.
Z-0038-2010	Airgas Puritan Medical Puritan Medical Unit	1	AGI-2238 Portable 4 Cylinder Manifold Cart, for connecting medical gas cylinders.
Z-0002-2016	Biosense Webster, Inc.	2	Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
Z-0032-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.
Z-0033-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 633.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033959233. Last updated year: 2026. Please use registration number 3033959233 when referencing this establishment in official correspondence.