Viasys Healthcare GmbH
Stoughton, WI, US
Viasys Healthcare GmbH appears in FDA device records in Stoughton, WI. FDA records list 17 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 17
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 17 510(k) clearances for Viasys Healthcare GmbH between 2003 and 2009. The busiest year on record is 2003, with 4. The most recent is 2009, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 4 |
| 2004 | 1 |
| 2006 | 1 |
| 2007 | 4 |
| 2008 | 3 |
| 2009 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K092324 | SPIROPRO | DQA | Substantially Equivalent | |
| K091412 | CLEAN PEAK FLOW METER | BZH | Substantially Equivalent | |
| K091505 | COR12+ | DSH | Substantially Equivalent | |
| K081823 | MASTERSCREEN PAED - BABY BODY | CCM | Substantially Equivalent | |
| K080510 | VIP PULMONARY FUNCTION SYSTEM | BTY | Substantially Equivalent | |
| K080734 | FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT | BTY | Substantially Equivalent | |
| K072061 | MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY | JEH | Substantially Equivalent | |
| K072323 | MASTERSCREEN & OXYCON CPX | BZC | Substantially Equivalent | |
| K071753 | MASTERSCREEN PNEUMO & MASTERSCOPE | BTY | Substantially Equivalent | |
| K062011 | MODIFICATION TO FLOWSCREEN | BTY | Substantially Equivalent | |
| K070614 | CORSCREEN | DPS | Substantially Equivalent | |
| K060421 | SONARA; SONARA/TEK | IYN | Substantially Equivalent | |
| K040698 | MASTERSCREEN CPX AND OXYCON CPX | BZC | Substantially Equivalent | |
| K031515 | SPIROPRO SPO2 | DQA | Substantially Equivalent | |
| K031713 | AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS | EWO | Substantially Equivalent | |
| K030517 | BALL RECORDING ELECTRODE/STIMULATION PROBE | GZK | Substantially Equivalent | |
| K031194 | SPIROSOFT | BTY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- EWOAudiometer
- BTYCalculator, Predicted Values, Pulmonary Function
- BZCCalculator, Pulmonary Function Data
- DPSElectrocardiograph
- GZKElectrode, Nasopharyngeal
- BZHMeter, Peak Flow, Spirometry
- DQAOximeter
- CCMPlethysmograph, Pressure
- JEHPlethysmograph, Volume
- DSHRecorder, Magnetic Tape, Medical
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain