Lme Blood Pressure Monitor
FDA 510(k) K832017 · Litton Medical Electronics
510(k) numberK832017
Submission
- Device name
- Lme Blood Pressure Monitor
- Applicant
- Litton Medical Electronics
Mchenry, IL, US - Received
- June 23, 1983
- Decision date
- October 31, 1983
- 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 |
|---|---|---|
| K840522 | Recomed Blood-Flow Meter H236-052-02DPW · Traditional | 05/16/1985SE |
| K840899 | Servomed Arrhycomp Central Monitor SysDSI · Traditional | 11/20/1984SE |
| K840439 | Recomed Cardiac Output Meter 236067-DXG · Traditional | 11/20/1984SE |
| K840523 | Servomed Pulse Amplifier MODULE-206-DRT · Traditional | 10/29/1984SE |
| K840524 | Servomed Basic Bedside Unit SMV 110TPDRT · Traditional | 10/26/1984SE |
| K840832 | Servomed Oxcardiore Spirograph 324/111DRT · Traditional | 09/20/1984SE |
| K840209 | Servomed Medivision Scope SMV-235DXJ · Traditional | 09/20/1984SE |
| K840525 | Servomed Compact Monitor SMK 155-1/101DRT · Traditional | 06/01/1984SE |
| K840521 | Servomed Digital Display ModuleDRT · Traditional | 06/01/1984SE |
| K834600 | Recomb ECG PREAMPLIFIER/206 069 03DRT · Traditional | 06/01/1984SE |
Questions and answers
When was Lme Blood Pressure Monitor cleared by the FDA?
Lme Blood Pressure Monitor (K832017) received a 510(k) decision of Substantially Equivalent on October 31, 1983, 130 days after the submission was received.
What is the product code of K832017?
The FDA product code is DSK – Computer, Blood-Pressure, a Class II (moderate risk) device regulated under 21 CFR 870.1110.