Company ยท US
Viasys Healthcare GmbH
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2009. Name variants (Inc, Corp, punctuation) are merged.
17510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| BTY | Calculator, Predicted Values, Pulmonary Function | 5 |
| BZC | Calculator, Pulmonary Function Data | 2 |
| DQA | Oximeter | 2 |
| BZH | Meter, Peak Flow, Spirometry | 1 |
| CCM | Plethysmograph, Pressure | 1 |
| DPS | Electrocardiograph | 1 |
| DSH | Recorder, Magnetic Tape, Medical | 1 |
| EWO | Audiometer | 1 |
| GZK | Electrode, Nasopharyngeal | 1 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 |
| JEH | Plethysmograph, Volume | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 3, 2009 | K092324 | SPIROPRO Viasys Healthcare GmbH, DE | DQA |
| Aug 21, 2009 | K091412 | CLEAN PEAK FLOW METER Viasys Healthcare GmbH, DE | BZH |
| Jun 10, 2009 | K091505 | COR12+ Viasys Healthcare GmbH, DE | DSH |
| May 18, 2009 | K081823 | MASTERSCREEN PAED - BABY BODY Viasys Healthcare GmbH, DE | CCM |
| Aug 20, 2008 | K080510 | VIP PULMONARY FUNCTION SYSTEM Viasys Healthcare GmbH, DE | BTY |
| Jun 26, 2008 | K080734 | FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT Viasys Healthcare GmbH, DE | BTY |
| Apr 22, 2008 | K072061 | MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY Viasys Healthcare GmbH | JEH |
| Oct 10, 2007 | K072323 | MASTERSCREEN & OXYCON CPX Viasys Healthcare GmbH | BZC |
| Aug 14, 2007 | K071753 | MASTERSCREEN PNEUMO & MASTERSCOPE Viasys Healthcare GmbH | BTY |
| May 11, 2007 | K062011 | MODIFICATION TO FLOWSCREEN Viasys Healthcare GmbH | BTY |
| May 4, 2007 | K070614 | CORSCREEN Viasys Healthcare GmbH, DE | DPS |
| Nov 3, 2006 | K060421 | SONARA; SONARA/TEK Viasys Healthcare, Inc. | IYN |
| Apr 7, 2004 | K040698 | MASTERSCREEN CPX AND OXYCON CPX Viasys Healthcare GmbH | BZC |
| Nov 14, 2003 | K031515 | SPIROPRO SPO2 Viasys Healthcare GmbH | DQA |
| Aug 12, 2003 | K031713 | AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS Viasys Healthcare, Inc. | EWO |
| Aug 1, 2003 | K030517 | BALL RECORDING ELECTRODE/STIMULATION PROBE Viasys Healthcare, Inc. | GZK |
| Jul 30, 2003 | K031194 | SPIROSOFT Viasys Healthcare GmbH | BTY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||