Compumedics USA, Inc.
Charlotte, NC, US
COMPUMEDICS USA, INC. appears in FDA device records in Charlotte, NC. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Compumedics USA, Inc. between 2003 and 2008. The busiest year on record is 2003, with 1. The most recent is 2008, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 1 |
| 2004 | 1 |
| 2008 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1650946 | 3002716534 | COMPUMEDICS USA, INC. | 5015 West WT Harris Blvd, Suite E, Charlotte, NC 28269 US | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- OLZAutomatic Event Detection Software For Polysomnograph With Electroencephalograph
- GXYElectrode, Cutaneous
- GWQFull-Montage Standard Electroencephalograph
- OLYMagnetoencephalograph
- GYBMedia, Electroconductive
- OMCReduced- Montage Standard Electroencephalograph
- OLXSource Localization Software For Electroencephalograph Or Magnetoencephalograph
- OLVStandard Polysomnograph With Electroencephalograph
- GWJStimulator, Auditory, Evoked Response
- GWFStimulator, Electrical, Evoked Response
- GWEStimulator, Photic, Evoked Response
- MNRVentilatory Effort Recorder
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0653-05 | Nonin Xpod Oximeter model numbers 3011 and 3012, distributed for use with the Compumedics E-Series Digital Amplifier. | Under specific conditions, the housing of the pulse oximeter contected to the amplifier can become excessively warm causing a burn upon contact with skin. | Terminated | ||
| Z-0652-05 | Compumedics E-Series Digital Amplifier System part number 8008-0001-01 and 8008-0001-02, manufactured by Compumedics Limited, Australia | Under specific conditions, the housing of the pulse oximeter contected to the amplifier can become excessively warm causing a burn upon contact with skin. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain