XR Model H Physiological Monitor & Recording Sys.
FDA 510(k) K901514 · Ppg Industries, Inc.
510(k) numberK901514
Submission
- Device name
- XR Model H Physiological Monitor & Recording Sys.
- Applicant
- Ppg Industries, Inc.
Lenexa, KS, US - Received
- March 30, 1990
- Decision date
- November 16, 1990
- 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
Other 510(k)s with product code DSK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K922631 | Statpal II Blood Gas Analysis SystemCHL · Traditional | 11/10/1992SE |
| K913358 | Midas System(Tm) 5100 Physiolog Monit/Record SystDXG · Traditional | 12/20/1991SE |
| K914560 | Stat Pal Sensyr Syringe Assembly for Use W/StatpalCHL · Traditional | 11/29/1991SE |
| K912627 | Midas System 2500, Physiological Monitoring SystemMHX · Traditional | 09/10/1991SE |
| K903965 | Statpal Blood Gas Monitoring SystemCHL · Traditional | 12/26/1990SE |
| K900246 | Cardiotest Ek 53 R, Cardiognost Ek 56/ Ek 512DSI · Traditional | 07/03/1990SE |
| K901132 | Sara SatcapCCK · Traditional | 05/22/1990SE |
| K896442 | PPG Biomedical Ventilator Model IrisaCBK · Traditional | 04/16/1990SE |
| K900700 | Smu 611 UniversalmonitorDPS · Traditional | 04/03/1990SE |
| K890875 | Cardiotest EK53/EK53R, Cardiognost EK56/EK512DPS · Traditional | 10/17/1989SE |
Questions and answers
When was XR Model H Physiological Monitor & Recording Sys. cleared by the FDA?
XR Model H Physiological Monitor & Recording Sys. (K901514) received a 510(k) decision of Substantially Equivalent on November 16, 1990, 231 days after the submission was received.
What is the product code of K901514?
The FDA product code is DSK – Computer, Blood-Pressure, a Class II (moderate risk) device regulated under 21 CFR 870.1110.