Cardiovit FT-1
FDA 510(k) K170182 · Schiller AG
510(k) numberK170182
Submission
- Device name
- Cardiovit FT-1
- Applicant
- Schiller AG
Baar, CH - Received
- January 23, 2017
- Decision date
- July 19, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K253562 | medilogFDMWJ · Traditional | 08/14/2026SE |
| K221056 | Argus PB-3000MHX · Traditional | 07/06/2023SE |
| K183425 | Cardiovit AT-102 G2DPS · Traditional | 03/02/2020SE |
| K152043 | Diagnostic Station DS20DPS · Traditional | 05/06/2016SE |
| K101619 | Welch Allyn 1500 Patient MonitorMHX · Traditional | 11/12/2010SE |
| K063814 | BP-200 PlusDXN · Traditional | 03/07/2007SE |
| K053207 | Argus, Model LCMMHX · Traditional | 05/19/2006SE |
| K051368 | BR 102 Plus Blood Pressure Holter SystemDXN · Traditional | 08/09/2005SE |
| K050686 | Cardiovit AT-10PLUSDPS · Traditional | 05/04/2005SE |
| K033738 | Monitoring System, Model Argus PB-2200DSK · Traditional | 08/24/2004SE |
Questions and answers
When was Cardiovit FT-1 cleared by the FDA?
Cardiovit FT-1 (K170182) received a 510(k) decision of Substantially Equivalent on July 19, 2017, 177 days after the submission was received.
What is the product code of K170182?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.