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FDA 510(k)

STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM

K-Number: K101046 · 2010-12-09

ApplicantSorin Group Deutschland GmbH
Decision Date2010-12-09
Product CodeDTX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Group Deutschland GmbH. It received FDA 510(k) clearance on 2010-12-09 under 510(k) number K101046. The device is classified under product code DTX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM?

STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM is a medical device that received FDA 510(k) clearance on 2010-12-09. The listed applicant is Sorin Group Deutschland GmbH. The 510(k) number is K101046.

When did STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM receive FDA 510(k) clearance?

STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM received FDA 510(k) clearance on 2010-12-09, under 510(k) number K101046.

Who is the listed applicant for STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM?

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

What is the FDA product code for STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM?

The FDA product code for STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM is DTX.

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Other records listing Sorin Group Deutschland 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.

K170460Sorin ConnectK131816SORIN CONNECT DATA MANAGEMENT SYSTEMK112225SORIN CENTRIFUGAL PUMP 5 (CP5)K103468STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS)K103762SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLEK103469STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05

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Related Devices (Code: DTX)

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.

K210669Quantum Mini Ventilation ModuleSpectrum Medical , Ltd.K202733Quantum Ventilation ModuleSpectrum Medical , Ltd.K181942Quantum Ventilation ModuleSpectrum Medical , Ltd.K023745SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-GSechrist Industries, Inc.K965214COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002)Coeur Laboratories, Inc.K863902MODIFIED SARNS MEMBRANE OXYGENATOR3M Health Care, Sarns

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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