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FDA 510(k)

NARCO TELECARE ISOFLO PRESSURE MONITOR

K-Number: K813502 · 1981-12-29

ApplicantNarco Bio-Systems
Decision Date1981-12-29
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NARCO TELECARE ISOFLO PRESSURE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Narco Bio-Systems. It received FDA 510(k) clearance on 1981-12-29 under 510(k) number K813502. 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 NARCO TELECARE ISOFLO PRESSURE MONITOR?

NARCO TELECARE ISOFLO PRESSURE MONITOR is a medical device that received FDA 510(k) clearance on 1981-12-29. The listed applicant is Narco Bio-Systems. The 510(k) number is K813502.

When did NARCO TELECARE ISOFLO PRESSURE MONITOR receive FDA 510(k) clearance?

NARCO TELECARE ISOFLO PRESSURE MONITOR received FDA 510(k) clearance on 1981-12-29, under 510(k) number K813502.

Who is the listed applicant for NARCO TELECARE ISOFLO PRESSURE MONITOR?

The FDA 510(k) record lists Narco Bio-Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NARCO TELECARE ISOFLO PRESSURE MONITOR?

The FDA product code for NARCO TELECARE ISOFLO PRESSURE MONITOR is DRS.

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Other records listing Narco Bio-Systems as applicant

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K853683UMS-100K833656NARCOTRACE 40 - NT40K832869MOTILITY MEASUREMENT SYS MMS-100K811376ULTRASONIC QFM SYSTEM 1000K810431NARCO TLECARE MINIATURE PRESSURE DOMEK801544PORTA-FIB LPD

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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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