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FDA 510(k)

NARCO TLECARE MINIATURE PRESSURE DOME

K-Number: K810431 · 1981-03-11

ApplicantNarco Bio-Systems
Decision Date1981-03-11
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NARCO TLECARE MINIATURE PRESSURE DOME 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 1981-03-11 under 510(k) number K810431. 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 TLECARE MINIATURE PRESSURE DOME?

NARCO TLECARE MINIATURE PRESSURE DOME is a medical device that received FDA 510(k) clearance on 1981-03-11. The listed applicant is Narco Bio-Systems. The 510(k) number is K810431.

When did NARCO TLECARE MINIATURE PRESSURE DOME receive FDA 510(k) clearance?

NARCO TLECARE MINIATURE PRESSURE DOME received FDA 510(k) clearance on 1981-03-11, under 510(k) number K810431.

Who is the listed applicant for NARCO TLECARE MINIATURE PRESSURE DOME?

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 TLECARE MINIATURE PRESSURE DOME?

The FDA product code for NARCO TLECARE MINIATURE PRESSURE DOME is DRS.

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Other records listing Narco Bio-Systems 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.

K853683UMS-100K833656NARCOTRACE 40 - NT40K832869MOTILITY MEASUREMENT SYS MMS-100K813502NARCO TELECARE ISOFLO PRESSURE MONITORK811376ULTRASONIC QFM SYSTEM 1000K801544PORTA-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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