Cosmed Quark C12/QUARK T12
FDA 510(k) K014262 · Cosmed Srl
510(k) numberK014262
Submission
- Device name
- Cosmed Quark C12/QUARK T12
- Applicant
- Cosmed Srl
West Cadwell, NJ, US - Received
- December 27, 2001
- Decision date
- March 26, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
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| K162515 | COSMED K5 Wearable Metabolic TechnologyBZC · Traditional | 06/20/2017SE |
| K120146 | Quark SeriesCBK · Traditional | 12/11/2012SE |
| K093174 | SpiropalmBZG · Traditional | 02/26/2010SE |
| K071533 | Fitmate SeriesBZL · Traditional | 09/28/2007SE |
| K040549 | Cosmed Pony FXBTY · Traditional | 09/28/2004SE |
| K020745 | Cosmed MicroquarkBTY · Traditional | 01/02/2003SE |
| K001174 | Cosmed QuarkBZC · Traditional | 01/11/2001SE |
| K963373 | Cosmed K4BZC · Traditional | 09/10/1997SE |
Questions and answers
When was Cosmed Quark C12/QUARK T12 cleared by the FDA?
Cosmed Quark C12/QUARK T12 (K014262) received a 510(k) decision of Substantially Equivalent on March 26, 2002, 89 days after the submission was received.
What is the product code of K014262?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.