Link to Acuity Clinician Notifier
FDA 510(k) K070204 · Welch Allyn Protocol, Inc.
510(k) numberK070204
Submission
- Device name
- Link to Acuity Clinician Notifier
- Applicant
- Welch Allyn Protocol, Inc.
Beaverton, OR, US - Received
- January 22, 2007
- Decision date
- March 23, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary 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
Other 510(k)s with product code MSX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261287 | Digistat CareMSX · Traditional | Ascom Ums Srl Unipersonale | 09/12/2026SE |
| K260211 | Dashboard (P007000)MSX · Traditional | Hill-Rom, Inc. | 08/13/2026SE |
| K261367 | Corsano CardioWatch 287-2 SystemMSX · Traditional | Corsano Health B.V. | 07/26/2026SE |
| K253654 | IntelliVue Measurement Rack 6000 (867317)MSX · Traditional | Philips Medizin Systeme Böblingen GmbH | 03/30/2026SE |
| K243270 | TigerConnect Alarm ManagementMSX · Traditional | Tigerconnect | 09/30/2025SE |
| 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 |
| K241397 | HinscopeMSX · Traditional | Hinlab Sas | 11/14/2024SE |
| K233834 | Infinity Gateway SuiteMSX · Traditional | Draeger Medical Systems, Inc. | 07/12/2024SE |
More from Draeger Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K063419 | Modification to Vsm- Vital Signs Monitor, (VSM 300 )MWI · Special | 12/04/2006SE |
| K033378 | Vital Signs Monitor, Propaq LTMWI · Traditional | 03/01/2004SE |
| K031740 | VSM - Vital Signs Monitor, Model 53000 SeriesDQA · Traditional | 08/26/2003SE |
| K022453 | Modification to Acuity Central Monitoring SystemDSI · Special | 08/21/2002SE |
| K021681 | Micropaq, Models 402, 404DRT · Special | 07/23/2002SE |
| K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246DRT · Special | 08/20/2001SE |
Questions and answers
When was Link to Acuity Clinician Notifier cleared by the FDA?
Link to Acuity Clinician Notifier (K070204) received a 510(k) decision of Substantially Equivalent on March 23, 2007, 60 days after the submission was received.
What is the product code of K070204?
The FDA product code is MSX – System, Network And Communication, Physiological Monitors, a Class II (moderate risk) device regulated under 21 CFR 870.2300.