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FDA 510(k)

ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM

K-Number: K070710 · 2007-04-19

ApplicantBiosensors International-USA
Decision Date2007-04-19
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biosensors International-USA. It received FDA 510(k) clearance on 2007-04-19 under 510(k) number K070710. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM?

ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2007-04-19. The listed applicant is Biosensors International-USA. The 510(k) number is K070710.

When did ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM receive FDA 510(k) clearance?

ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM received FDA 510(k) clearance on 2007-04-19, under 510(k) number K070710.

Who is the listed applicant for ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM?

The FDA 510(k) record lists Biosensors International-USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM?

The FDA product code for ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM is DRS.

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Other records listing Biosensors International-USA as applicant

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Related Devices (Code: DRS)

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.

K254074TruPressProcerus EnterprisesK242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLCK221782Meritrans ECO Reusable Pressure Transducer, Meritrans ECO DomesMerit Medical Pte. , Ltd.K172458HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer KitSmiths Medical Asd, Inc.K163172HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer KitSmiths Medical Asd, Inc.K161408Compass Cast and MAPCenturion Medical Products Corporation

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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