Zoll Rescuenet 12-LEAD
FDA 510(k) K121865 · ZOLL Medical Corporation
510(k) numberK121865
Submission
- Device name
- Zoll Rescuenet 12-LEAD
- Applicant
- ZOLL Medical Corporation
Chelsmford, MA, US - Received
- June 26, 2012
- Decision date
- November 20, 2012
- 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 |
|---|---|---|
| K233486 | 731 Series VentilatorCBK · Traditional | 12/13/2024SE |
| K202375 | ZOLL Propaq MMWI · Traditional | 03/09/2021SE |
| K180482 | ZOLL Propaq MMHX · Traditional | 11/30/2018SE |
| K172653 | Power InfuserFRN · Traditional | 07/18/2018SE |
| K162832 | 731 Series VentilatorsCBK · Traditional | 08/02/2017SE |
| K170533 | Model 330 Multifunction AspiratorBTA · Traditional | 04/18/2017SE |
| K142915 | ZOLL X SeriesMKJ · Traditional | 12/03/2014SE |
| K141774 | Zoll X SeriesMKJ · Traditional | 11/19/2014SE |
| K140502 | Zoll E Series AlsLDD · Traditional | 11/06/2014SE |
| K133484 | Zoll X SeriesMKJ · Traditional | 08/01/2014SE |
Questions and answers
When was Zoll Rescuenet 12-LEAD cleared by the FDA?
Zoll Rescuenet 12-LEAD (K121865) received a 510(k) decision of Substantially Equivalent on November 20, 2012, 147 days after the submission was received.
What is the product code of K121865?
The FDA product code is MSX – System, Network And Communication, Physiological Monitors, a Class II (moderate risk) device regulated under 21 CFR 870.2300.