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FDA 510(k)

STOCKERT HEATER-COOLER SYSTEM 3T

K-Number: K052601 · 2006-06-06

ApplicantSorin Group Deutschland GmbH
Decision Date2006-06-06
Product CodeDWC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STOCKERT HEATER-COOLER SYSTEM 3T 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 2006-06-06 under 510(k) number K052601. The device is classified under product code DWC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STOCKERT HEATER-COOLER SYSTEM 3T?

STOCKERT HEATER-COOLER SYSTEM 3T is a medical device that received FDA 510(k) clearance on 2006-06-06. The listed applicant is Sorin Group Deutschland GmbH. The 510(k) number is K052601.

When did STOCKERT HEATER-COOLER SYSTEM 3T receive FDA 510(k) clearance?

STOCKERT HEATER-COOLER SYSTEM 3T received FDA 510(k) clearance on 2006-06-06, under 510(k) number K052601.

Who is the listed applicant for STOCKERT HEATER-COOLER SYSTEM 3T?

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 HEATER-COOLER SYSTEM 3T?

The FDA product code for STOCKERT HEATER-COOLER SYSTEM 3T is DWC.

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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: DWC)

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.

K220635Heater-Cooler System 3TLivanova Deutschland, GmbHK212657Quantum Heater-CoolerSpectrum Medical , Ltd.K191402Heater-Cooler System 3TLivanova Deutschland, GmbHK130300HEATER-COOLER UNIT HCU 40Maquet Cardiopulmonary, AGK122813HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEMCincinnati Sub-Zero Products, Inc.K102147CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000Cardioquip Llp

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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