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FDA 510(k)

S3 CYCLIC RPM CONTROL

K-Number: K971520 · 1997-09-10

ApplicantStoeckert Instrumente
Decision Date1997-09-10
Product CodeDWB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

S3 CYCLIC RPM CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Stoeckert Instrumente. It received FDA 510(k) clearance on 1997-09-10 under 510(k) number K971520. The device is classified under product code DWB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S3 CYCLIC RPM CONTROL?

S3 CYCLIC RPM CONTROL is a medical device that received FDA 510(k) clearance on 1997-09-10. The listed applicant is Stoeckert Instrumente. The 510(k) number is K971520.

When did S3 CYCLIC RPM CONTROL receive FDA 510(k) clearance?

S3 CYCLIC RPM CONTROL received FDA 510(k) clearance on 1997-09-10, under 510(k) number K971520.

Who is the listed applicant for S3 CYCLIC RPM CONTROL?

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

What is the FDA product code for S3 CYCLIC RPM CONTROL?

The FDA product code for S3 CYCLIC RPM CONTROL is DWB.

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Other records listing Stoeckert Instrumente 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.

K002273STOCKERT A272 SERIES PEDIATRIC AORTIC CANNULAEK001961STOCKERT A242 AND A252 SERIES ARTERIAL FEMORAL CANNULAEK002118STOCKERT COMPACT SYSTEM VERSION 2.0K992635INTERFACE MODULE IDDDK990512STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTSK982014STOCKERT COMPACT SYSTEM

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Related Devices (Code: DWB)

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.

K162843Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationK131618LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTTerumo Cardiovascular Systems CorporationK112587ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR,Terumo Cardiovascular Systems Corp.K973237CSS-CARDIOPLEGIA SAFETY SYSTEMMedtronic Bio-Medicus, Inc.K972321S3 MAST PUMPStoeckert InstrumenteK960974COBE CENTURY PERFUSION PUMPCobe Cardiovascular, Inc.

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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