Kontron Kolormon 7250 Patient Monitor
FDA 510(k) K896417 · Kontron Instruments, Inc.
510(k) numberK896417
Submission
- Device name
- Kontron Kolormon 7250 Patient Monitor
- Applicant
- Kontron Instruments, Inc.
Everett, MA, US - Received
- November 8, 1989
- Decision date
- December 12, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K971038 | Kontron Kolormon Plus ECG with Respiration ModuleDPS · Traditional | 09/24/1997SE |
| K932268 | Modifications to Intra-Aortic BalloonsDSP · Traditional | 12/15/1993SE |
| K925248 | Modification of Intra-Aortic Balloon CathetersDSP · Traditional | 09/27/1993SE |
| K923603 | Intra-Aortic Balloon Pump Catheter - ModificationDYB · Traditional | 03/08/1993SE |
| K905313 | Kontron Intra-Aortic Balloon Pump, Model Kaat IIDSP · Traditional | 06/19/1991SE |
| K903344 | 9.5 FR Percutaneous DB Lumen 40CC Flexi-Cath (TM)DSP · Traditional | 01/15/1991SE |
| K896437 | Kontron Sigma 44 HVCD Ultrasound Imaging SystemDPT · Traditional | 12/03/1990SE |
| K892222 | 9.5F Percu Double Lumen Intra-Aortic BalloonDSP · Traditional | 09/14/1990SE |
| K882955 | Supermon Neonatal Non-Invasive Blood Press. 7283DXN · Traditional | 01/26/1990SE |
| K896386 | Minimon 7133B Patient MonitorDPS · Traditional | 12/13/1989SE |
Questions and answers
When was Kontron Kolormon 7250 Patient Monitor cleared by the FDA?
Kontron Kolormon 7250 Patient Monitor (K896417) received a 510(k) decision of Substantially Equivalent on December 12, 1989, 34 days after the submission was received.
What is the product code of K896417?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.