H59 Critical Care Monitor
FDA 510(k) K791839 · Medtel Pty. , Ltd.
510(k) numberK791839
Submission
- Device name
- H59 Critical Care Monitor
- Applicant
- Medtel Pty. , Ltd.
Mchenry, IL, US - Received
- September 14, 1979
- Decision date
- October 1, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DSK – Computer, Blood-Pressure
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1110
- Specialty
- Cardiovascular
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|---|---|---|---|
| K231586 | Endophys Blood Pressure Monitor model BPM-30DSK · Traditional | Endophys Technologies, LLC | 11/03/2023SE |
| K160945 | Endophys Blood Pressure MonitorDSK · Traditional | Endophys Holdings, LLC | 09/26/2016SE |
| K152582 | CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter BoxDSK · Special | Volcano Corporation | 12/03/2015SE |
| K141615 | Endophys Blood Pressure MonitorDSK · Traditional | Endophys, Inc. | 01/07/2015SE |
| K080670 | Modification to Sphygmocor Cardiovascular Management SystemDSK · Special | Atcor Medical | 04/23/2008SE |
| K070795 | Sphygmocor Cardiovascular Management SystemDSK · Traditional | Atcor Medical Pty, Ltd. | 08/31/2007SE |
| K033738 | Monitoring System, Model Argus PB-2200DSK · Traditional | Schiller AG | 08/24/2004SE |
| K021517 | Abp for WindowsDSK · Traditional | Rozinn Electronics, Inc. | 07/24/2002SE |
| K013943 | Radianalyzer, Model 12710, Radiview (Pc-Software Accessory), Model 12720DSK · Special | Radi Medical Systems AB | 12/18/2001SE |
| K011865 | Zoll M Series Ibp Operation; Zoll M Series Temperature OptionDSK · Traditional | Zoll Medical Corp | 07/31/2001SE |
More from Zoll Medical Corp
| 510(k) | Device | Decision |
|---|---|---|
| K832356 | Portable Operat. Rm. Monitors HS30/40BZN · Traditional | 10/28/1983SE |
| K820670 | HS17/HS18 Series MonitorsFLL · Traditional | 04/09/1982SE |
| K820671 | CM10 Central Monitoring SystemDRT · Traditional | 04/01/1982SE |
| K820399 | HS20 Port. Operating Room MonitorDRT · Traditional | 03/22/1982SE |
| K802184 | HS10 Portable Operating Room MonitorDRT · Traditional | 09/26/1980SE |
| K800243 | D668 & D664 Central Monitoring SystemsDRT · Traditional | 04/10/1980SE |
| K791838 | HSH/H512 Adult Physiological MonitorsDSK · Traditional | 10/01/1979SE |
Questions and answers
When was H59 Critical Care Monitor cleared by the FDA?
H59 Critical Care Monitor (K791839) received a 510(k) decision of Substantially Equivalent on October 1, 1979, 17 days after the submission was received.
What is the product code of K791839?
The FDA product code is DSK – Computer, Blood-Pressure, a Class II (moderate risk) device regulated under 21 CFR 870.1110.