Corscreen
FDA 510(k) K070614 · Viasys Healthcare GmbH
510(k) numberK070614
Submission
- Device name
- Corscreen
- Applicant
- Viasys Healthcare GmbH
Hoechberg, DE - Received
- March 5, 2007
- Decision date
- May 4, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- DPS – Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2340
- Specialty
- Cardiovascular
Other 510(k)s with product code DPS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252463 | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)DPS · Traditional | Edan Instruments, Inc. | 07/02/2026SE |
| K251670 | MAC 7 Resting ECG Analysis SystemDPS · Traditional | Ge Medical Systems Information Technologies, Inc. | 01/26/2026SE |
| K252361 | AccurECG Analysis System (v2.0)DPS · Traditional | Accurkardia, Inc. | 12/22/2025SE |
| K252474 | Withings BeamO (SCT02)DPS · Traditional | Withings | 11/10/2025SE |
| K250569 | Cardiologs Holter PlatformDPS · Traditional | Philips France Commercial | 08/06/2025SE |
| K243252 | ZBPro DiagnosticDPS · Traditional | Zbeats, Inc. | 07/10/2025SE |
| K243305 | Masimo W1DPS · Traditional | Masimo Corporation | 04/03/2025SE |
| K241217 | CloudHRV System (100-01-001)DPS · Traditional | Inmedix, Inc. | 01/16/2025SE |
| K241556 | Cardiac Workstation (5000); Cardiac Workstation (7000)DPS · Traditional | Philips Medizin Systeme Böblingen GmbH | 12/17/2024SE |
| K240229 | Masimo W1DPS · Traditional | Masimo Corporation | 08/08/2024SE |
More from Masimo Corporation
| 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 |
| K072061 | Masterscreen PFT, Masterscreen PFT CT, Masterscreen PFT BodyJEH · Traditional | 04/22/2008SE |
| K072323 | Masterscreen & Oxycon CPXBZC · Special | 10/10/2007SE |
| K071753 | Masterscreen Pneumo & MasterscopeBTY · Special | 08/14/2007SE |
| K062011 | Modification to FlowscreenBTY · Special | 05/11/2007SE |
Questions and answers
When was Corscreen cleared by the FDA?
Corscreen (K070614) received a 510(k) decision of Substantially Equivalent on May 4, 2007, 60 days after the submission was received.
What is the product code of K070614?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.