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FDA 510(k)

STOCKERT SCP RHYTHM

K-Number: K042374 · 2004-09-23

ApplicantStockert Instrumente GmbH
Decision Date2004-09-23
Product CodeDWA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STOCKERT SCP RHYTHM is the device name listed in this FDA 510(k) record. The listed applicant is Stockert Instrumente GmbH. It received FDA 510(k) clearance on 2004-09-23 under 510(k) number K042374. The device is classified under product code DWA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STOCKERT SCP RHYTHM?

STOCKERT SCP RHYTHM is a medical device that received FDA 510(k) clearance on 2004-09-23. The listed applicant is Stockert Instrumente GmbH. The 510(k) number is K042374.

When did STOCKERT SCP RHYTHM receive FDA 510(k) clearance?

STOCKERT SCP RHYTHM received FDA 510(k) clearance on 2004-09-23, under 510(k) number K042374.

Who is the listed applicant for STOCKERT SCP RHYTHM?

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

What is the FDA product code for STOCKERT SCP RHYTHM?

The FDA product code for STOCKERT SCP RHYTHM is DWA.

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Other records listing Stockert Instrumente GmbH 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.

K041558STOCKERTIR PURGE CONTROL (APC) SYSTEMK032213STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMPK023622STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35K022280STOCKERT CORONARY PERFUSION CANNULAEK022321STOCKERT V172-28 VENOUS FEMORAL CANNULAK020571STOCKERT CENTRIFUGAL PUMP CONSOLE

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Related Devices (Code: DWA)

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.

K232788INSPIRA ART100Inspira Technologies Oxy B.H.N. , Ltd.K230698Anivia SG1000 Pump ConsoleApmtd, Inc.K221491Anivia SG1000 Pump ConsoleApmtd, Inc.K192838Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium PressureSpectrum Medical , Ltd.K200306CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula KitAbbott (Formerly Thoratec Corporation)K191557CentriMag Acute Circulatory Support SystemThoratec Corporation (Now Part of Abbott)

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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