Masterscreen PFT, Masterscreen PFT CT, Masterscreen PFT Body
FDA 510(k) K072061 · Viasys Healthcare GmbH
510(k) numberK072061
Submission
- Device name
- Masterscreen PFT, Masterscreen PFT CT, Masterscreen PFT Body
- Applicant
- Viasys Healthcare GmbH
Yorba Linda, CA, US - Received
- July 27, 2007
- Decision date
- April 22, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JEH – Plethysmograph, Volume
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1760
- Specialty
- Anesthesiology
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|---|---|---|---|
| K240706 | PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+)…JEH · Traditional | Ganshorn Medizin Electronic GmbH | 12/09/2024SE |
| K223818 | Model 9160 VitaloQUBJEH · Traditional | Vitalograph Ireland, Ltd. | 05/25/2023SE |
| K022636 | Body Box 5500JEH · Traditional | Morgan Scientific, Inc. | 01/13/2003SE |
| K960840 | C.E. Vascular MachineJEH · Traditional | C.E. Diagnosis, Inc. | 03/28/1997SE |
| K953642 | AP-18JEH · Traditional | Jeneric/Pentron, Inc. | 12/12/1995SE |
| K951901 | Masterscreen PFT BodyJEH · Traditional | Erich Jaeger GmbH & Co. KG | 07/31/1995SE |
| K936108 | Masterscreen BodyJEH · Traditional | Erich Jaeger GmbH & Co. KG | 02/03/1995SE |
| K932812 | Ec 5R PlethysmographJEH · Traditional | D. E. Hokanson, Inc. | 01/13/1994SE |
| K925040 | TelepulseJEH · Traditional | Biometrix , Ltd. | 08/23/1993SE |
| K851197 | Cybermedic CM-810 Body PlethysmographJEH · Traditional | Cybermedic, Inc. | 07/08/1985SE |
More from Cybermedic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K092324 | SpiroproDQA · Special | 09/03/2009SE |
| K091412 | Clean Peak Flow MeterBZH · Special | 08/21/2009SE |
| K091505 | COR12+DSH · Traditional | 06/10/2009SE |
| K081823 | Masterscreen Paed - Baby BodyCCM · Traditional | 05/18/2009SE |
| K080510 | Vip Pulmonary Function SystemBTY · Special | 08/20/2008SE |
| K080734 | Flowscreen, Flowscreen/Corscreen, Flowscreen CTBTY · Traditional | 06/26/2008SE |
| K072323 | Masterscreen & Oxycon CPXBZC · Special | 10/10/2007SE |
| K071753 | Masterscreen Pneumo & MasterscopeBTY · Special | 08/14/2007SE |
| K062011 | Modification to FlowscreenBTY · Special | 05/11/2007SE |
| K070614 | CorscreenDPS · Traditional | 05/04/2007SE |
Questions and answers
When was Masterscreen PFT, Masterscreen PFT CT, Masterscreen PFT Body cleared by the FDA?
Masterscreen PFT, Masterscreen PFT CT, Masterscreen PFT Body (K072061) received a 510(k) decision of Substantially Equivalent on April 22, 2008, 270 days after the submission was received.
What is the product code of K072061?
The FDA product code is JEH – Plethysmograph, Volume, a Class II (moderate risk) device regulated under 21 CFR 868.1760.