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FDA 510(k)

MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM

K-Number: K080670 · 2008-04-23

ApplicantAtcor Medical
Decision Date2008-04-23
Product CodeDSK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Atcor Medical. It received FDA 510(k) clearance on 2008-04-23 under 510(k) number K080670. The device is classified under product code DSK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM?

MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2008-04-23. The listed applicant is Atcor Medical. The 510(k) number is K080670.

When did MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM received FDA 510(k) clearance on 2008-04-23, under 510(k) number K080670.

Who is the listed applicant for MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM?

The FDA 510(k) record lists Atcor Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM?

The FDA product code for MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM is DSK.

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Other records listing Atcor Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221742CONNEQT PULSEK122129SPHYGMOCOR XCEL

Related Devices (Code: DSK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231586Endophys Blood Pressure Monitor model BPM-30Endophys Technologies, LLCK160945Endophys Blood Pressure MonitorEndophys Holdings, LLCK070795SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEMAtcor Medical Pty, Ltd.K033738MONITORING SYSTEM, MODEL ARGUS PB-2200Schiller AGK021517ABP FOR WINDOWSRozinn Electronics, Inc.K013943RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720Radi Medical Systems AB

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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