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FDA 510(k)

MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP

K-Number: K980946 · 1998-06-08

ApplicantDentsleeve Pty., Ltd.
Decision Date1998-06-08
Product CodeFFX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Dentsleeve Pty., Ltd.. It received FDA 510(k) clearance on 1998-06-08 under 510(k) number K980946. The device is classified under product code FFX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP?

MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP is a medical device that received FDA 510(k) clearance on 1998-06-08. The listed applicant is Dentsleeve Pty., Ltd.. The 510(k) number is K980946.

When did MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP receive FDA 510(k) clearance?

MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP received FDA 510(k) clearance on 1998-06-08, under 510(k) number K980946.

Who is the listed applicant for MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP?

The FDA 510(k) record lists Dentsleeve Pty., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP?

The FDA product code for MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP is FFX.

Related Clinical Trials

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.

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Other records listing Dentsleeve Pty., Ltd. 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.

K013154MARK II/MARK III MANOMETRIC PERFUSION PUMPK983665MANOMETRIC ASSEMBLIES

Related Devices (Code: FFX)

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.

K252605mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)Medspira, LLCK240007Solar Compact (G4-1)Laborie Medical Technologies, Corp.K231861EndoflipTM 300 SystemCovidien, LLCK223705EndoflipTM 300Covidien, LLCK222000Transit-PelletsMedifactia ABK201106IntraMarX 3D Radiopaque MarkerAnx Robotica Corp

Official Source

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

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