Draeger Medical Systems, Inc.

Entity profile compiled from public source records

Public Record Profile Registrations: 2 510(k) filings: 1 Recalls: 1

Known Identifiers & Locations

FEI Numbers 2510954, 3005783425
Owner Operator Numbers 9070398
Locations Covered ANDOVER, MA, US; Telford, PA, US

Registered Establishments (2)

Registration # Establishment Name Location Establishment Type(s) Action
2510954 DRAEGER MEDICAL SYSTEMS, INC. Telford, PA, US Manufacture Medical Device View Details
3005783425 DRAEGER MEDICAL SYSTEMS, INC. ANDOVER, MA, US Manufacture Medical Device View Details

510(k) Premarket Notifications (1)

Submission # Device Name Decision Date Decision Description Action
K051628 INFINITY MONITORS WITH SCIO MODIFICATIONS 2005-07-20 Substantially Equivalent View Details

FDA Recall History (1)

Recall # Product Description Initiation Date Status Action
Z-0018-2011 Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969. Reason: Patients received insufficient ventilation. The Oxylog 3000 Instructions are inadequate relating to dead space volume. 2010-08-19 Terminated View Details

Profile Disclaimer

AvaSpecs compiles public data records from the FDA database. This compiled profile does not indicate endorsement, safety, clearance, approval, or compliance status. AvaSpecs is a private search index and is not affiliated with the FDA or any government agency.

Account Required Full available specs will require a free AvaSpecs account.