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FDA 510(k)

COBE DISPOSABLE PRESSURE TRANSDUCER

K-Number: K810637 · 1981-04-23

ApplicantCobe Laboratories, Inc.
Decision Date1981-04-23
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COBE DISPOSABLE PRESSURE TRANSDUCER is the device name listed in this FDA 510(k) record. The listed applicant is Cobe Laboratories, Inc.. It received FDA 510(k) clearance on 1981-04-23 under 510(k) number K810637. 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 COBE DISPOSABLE PRESSURE TRANSDUCER?

COBE DISPOSABLE PRESSURE TRANSDUCER is a medical device that received FDA 510(k) clearance on 1981-04-23. The listed applicant is Cobe Laboratories, Inc.. The 510(k) number is K810637.

When did COBE DISPOSABLE PRESSURE TRANSDUCER receive FDA 510(k) clearance?

COBE DISPOSABLE PRESSURE TRANSDUCER received FDA 510(k) clearance on 1981-04-23, under 510(k) number K810637.

Who is the listed applicant for COBE DISPOSABLE PRESSURE TRANSDUCER?

The FDA 510(k) record lists Cobe Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COBE DISPOSABLE PRESSURE TRANSDUCER?

The FDA product code for COBE DISPOSABLE PRESSURE TRANSDUCER is DRS.

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Other records listing Cobe Laboratories, Inc. as applicant

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K923272COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATORK900105COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTICK905793COBE CENTRY 2 BICART OPTION KITK905388COBE CENTRYSYSTEM 3 BICART OPTION KITK904336NEW COBE SATURATION/HEMATOCRIT MONITORK902437COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER

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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

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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