Q-Stress and Heartstride, Models QSTRESS/Q40 and H4/H4S
FDA 510(k) K082173 · Cardiac Science Corporation
510(k) numberK082173
Submission
- Device name
- Q-Stress and Heartstride, Models QSTRESS/Q40 and H4/H4S
- Applicant
- Cardiac Science Corporation
Bothell, WA, US - Received
- August 1, 2008
- Decision date
- August 26, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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|---|---|---|---|
| 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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| K122758 | Powerheart G5 AEDMKJ · Traditional | 02/12/2014SE |
| K113176 | Mysense HeartDSH · Traditional | 12/21/2011SE |
| K102496 | Powerheart AED G3 Semi-Automatic, Powerheart AED G3 Automatic, Powerheart AED G3 Pro…MKJ · Special | 06/09/2011SE |
| K093211 | Carecenter MDDPS · Traditional | 06/03/2010SE |
| K091943 | Powerheart AED G3, Model 9390E, Powerheart AED G3 Automatic, Model 9390AMKJ · Special | 09/10/2009SE |
| K082090 | 9131 Defibrillation ElectrodesMKJ · Special | 12/12/2008SE |
| K060934 | Modification to Powerheart EcdMKJ · Special | 05/15/2006SE |
| K060167 | Atria 3100, Atria 6100DPS · Abbreviated | 04/19/2006SE |
| K052316 | Powerheart EcdMKJ · Traditional | 01/03/2006SE |
Questions and answers
When was Q-Stress and Heartstride, Models QSTRESS/Q40 and H4/H4S cleared by the FDA?
Q-Stress and Heartstride, Models QSTRESS/Q40 and H4/H4S (K082173) received a 510(k) decision of Substantially Equivalent on August 26, 2008, 25 days after the submission was received.
What is the product code of K082173?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.