Vita-Stat Model 9000-A

FDA 510(k) K811147 · Vita-Stat

Substantially Equivalent

510(k) numberK811147

Submission

Device name
Vita-Stat Model 9000-A
Applicant
Vita-Stat
Mchenry, IL, US
Received
April 27, 1981
Decision date
June 30, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

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)DeviceApplicantDecision
K231586Endophys Blood Pressure Monitor model BPM-30DSK · Traditional Endophys Technologies, LLC11/03/2023SE
K160945Endophys Blood Pressure MonitorDSK · Traditional Endophys Holdings, LLC09/26/2016SE
K152582CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter BoxDSK · Special Volcano Corporation12/03/2015SE
K141615Endophys Blood Pressure MonitorDSK · Traditional Endophys, Inc.01/07/2015SE
K080670Modification to Sphygmocor Cardiovascular Management SystemDSK · Special Atcor Medical04/23/2008SE
K070795Sphygmocor Cardiovascular Management SystemDSK · Traditional Atcor Medical Pty, Ltd.08/31/2007SE
K033738Monitoring System, Model Argus PB-2200DSK · Traditional Schiller AG08/24/2004SE
K021517Abp for WindowsDSK · Traditional Rozinn Electronics, Inc.07/24/2002SE
K013943Radianalyzer, Model 12710, Radiview (Pc-Software Accessory), Model 12720DSK · Special Radi Medical Systems AB12/18/2001SE
K011865Zoll M Series Ibp Operation; Zoll M Series Temperature OptionDSK · Traditional Zoll Medical Corp07/31/2001SE

More from Zoll Medical Corp

510(k)DeviceDecision
K895586Vvr/Q CalorimeterBZL · Traditional 09/22/1989SE
K811146Vita-Stat Model 8000-CDSK · Traditional 06/30/1981SE

Questions and answers

When was Vita-Stat Model 9000-A cleared by the FDA?

Vita-Stat Model 9000-A (K811147) received a 510(k) decision of Substantially Equivalent on June 30, 1981, 64 days after the submission was received.

What is the product code of K811147?

The FDA product code is DSK – Computer, Blood-Pressure, a Class II (moderate risk) device regulated under 21 CFR 870.1110.