Datex-Engstrom Network
FDA 510(k) K974101 · Datex-Engstrom, Inc.
510(k) numberK974101
Submission
- Device name
- Datex-Engstrom Network
- Applicant
- Datex-Engstrom, Inc.
Tewksbury, MA, US - Received
- October 30, 1997
- Decision date
- February 6, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MSX – System, Network And Communication, Physiological Monitors
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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| K253654 | IntelliVue Measurement Rack 6000 (867317)MSX · Traditional | Philips Medizin Systeme Böblingen GmbH | 03/30/2026SE |
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| K242728 | BeneVision Central Monitoring SystemMSX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 07/31/2025SE |
| K242750 | Central StationMSX · Traditional | Nihon Kohden Digital Health Solutions, LLC | 06/05/2025SE |
| K242842 | ANNE View, Central HubMSX · Traditional | Sibel Health, Inc. | 01/08/2025SE |
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More from Draeger Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K983366 | Trip Tonometry Catheter, 16FKNT · Traditional | 12/23/1998SE |
| K982091 | CS/3 Compact Airway Module, M-CovxMHX · Traditional | 12/22/1998SE |
| K981378 | Datex-Engstrom Light Monitor Models F-LM1, F-LMP1DRT · Traditional | 11/03/1998SE |
| K973985 | AS/3 Anaesthesia Delivery Unit (AS/3 Adu)BSZ · Traditional | 10/30/1998SE |
| K980362 | MRI Compatible Monitor and AccessoriesDPS · Traditional | 06/30/1998SE |
| K974792 | CS/3(TM) Monitors*DSI · Traditional | 06/02/1998SE |
| K980384 | Trip Tonometry Catheter, 18FCCK · Traditional | 05/01/1998SE |
| K974747 | CS/3 Arrhythmia WorkstationDSI · Traditional | 04/23/1998SE |
| K964204 | Engstrom Hmef 1000CAH · Traditional | 11/13/1996SE |
Questions and answers
When was Datex-Engstrom Network cleared by the FDA?
Datex-Engstrom Network (K974101) received a 510(k) decision of Substantially Equivalent on February 6, 1998, 99 days after the submission was received.
What is the product code of K974101?
The FDA product code is MSX – System, Network And Communication, Physiological Monitors, a Class II (moderate risk) device regulated under 21 CFR 870.2300.