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FDA 510(k)

COBE PATIENT MONITORING PRODUCTS

K-Number: K921343 · 1993-01-05

ApplicantCobe Cardiovascular, Inc.
Decision Date1993-01-05
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COBE PATIENT MONITORING PRODUCTS is the device name listed in this FDA 510(k) record. The listed applicant is Cobe Cardiovascular, Inc.. It received FDA 510(k) clearance on 1993-01-05 under 510(k) number K921343. 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 PATIENT MONITORING PRODUCTS?

COBE PATIENT MONITORING PRODUCTS is a medical device that received FDA 510(k) clearance on 1993-01-05. The listed applicant is Cobe Cardiovascular, Inc.. The 510(k) number is K921343.

When did COBE PATIENT MONITORING PRODUCTS receive FDA 510(k) clearance?

COBE PATIENT MONITORING PRODUCTS received FDA 510(k) clearance on 1993-01-05, under 510(k) number K921343.

Who is the listed applicant for COBE PATIENT MONITORING PRODUCTS?

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

What is the FDA product code for COBE PATIENT MONITORING PRODUCTS?

The FDA product code for COBE PATIENT MONITORING PRODUCTS is DRS.

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Other records listing Cobe Cardiovascular, Inc. as applicant

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K050111SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAGK042473COBE ANGEL WHOLE BLOOD SEPARATION SYSTEMK040184DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTERK033641SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800K030462COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700K021830SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM

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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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