IMS-2000S Stress Monitor
FDA 510(k) K871659 · Integrated Medical Systems, Inc.
510(k) numberK871659
Submission
- Device name
- IMS-2000S Stress Monitor
- Applicant
- Integrated Medical Systems, Inc.
Golden, CO, US - Received
- April 28, 1987
- Decision date
- May 28, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXG – Computer, Diagnostic, Pre-Programmed, Single-Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1435
- Specialty
- Cardiovascular
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| K181372 | ArgosDXG · Traditional | Retia Medical, LLC | 12/13/2018SE |
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| K163334 | LiDCOunity v2 Hemodynamic MonitorDXG · Traditional | Lidco, Ltd. | 06/05/2017SE |
More from Lidco, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K082256 | Life Support for Trauma and Trnsport (Lstat) G6 LiteMWI · Traditional | 09/26/2008SE |
| K902682 | Stick-Gard Sterile CapLDQ · Traditional | 09/26/1990SE |
| K895414 | Multimed (TM) Pulmonary Function Testing SystemBZG · Traditional | 02/12/1990SE |
| K870934 | IMS-2000R Resting Electrocardiographic SystemDXG · Traditional | 05/06/1987SE |
Questions and answers
When was IMS-2000S Stress Monitor cleared by the FDA?
IMS-2000S Stress Monitor (K871659) received a 510(k) decision of Substantially Equivalent on May 28, 1987, 30 days after the submission was received.
What is the product code of K871659?
The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.