Zoll Rescuenetlink
FDA 510(k) K111296 · Zoll Medical Corporation, World Wide Headquarters
510(k) numberK111296
Submission
- Device name
- Zoll Rescuenetlink
- Applicant
- Zoll Medical Corporation, World Wide Headquarters
Chelsmford, MA, US - Received
- May 9, 2011
- Decision date
- October 27, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
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| 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 |
|---|---|---|
| K133239 | Zoll E SeriesMKJ · Traditional | 01/16/2015SE |
| K133269 | Zoll X SeriesMKJ · Traditional | 05/22/2014SE |
| K120406 | Zoll Fully Automatic AED PlusMKJ · Traditional | 10/26/2012SE |
| K120907 | Zoll R SeriesMKJ · Traditional | 09/25/2012SE |
| K112761 | Zoll Propaq MDMKJ · Traditional | 04/25/2012SE |
| K112432 | Zoll X SeriesMKJ · Traditional | 03/21/2012SE |
| K111594 | Zoll E SeriesMKJ · Traditional | 08/17/2011SE |
| K110361 | Zoll R Series with 2010 Aha Guidelines Software UpdateMKJ · Special | 03/08/2011SE |
| K110168 | Zoll E Series with 2010 Aha Guidlines Software UpdateMKJ · Special | 02/17/2011SE |
| K110154 | Zoll AED Plus with 2010 Aha Guidlines Software UpdateMKJ · Special | 02/17/2011SE |
Questions and answers
When was Zoll Rescuenetlink cleared by the FDA?
Zoll Rescuenetlink (K111296) received a 510(k) decision of Substantially Equivalent on October 27, 2011, 171 days after the submission was received.
What is the product code of K111296?
The FDA product code is MSX – System, Network And Communication, Physiological Monitors, a Class II (moderate risk) device regulated under 21 CFR 870.2300.