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FDA 510(k)

SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESS

K-Number: K873168 · 1988-01-12

ApplicantSpectramed, Inc.
Decision Date1988-01-12
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESS is the device name listed in this FDA 510(k) record. The listed applicant is Spectramed, Inc.. It received FDA 510(k) clearance on 1988-01-12 under 510(k) number K873168. 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 SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESS?

SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESS is a medical device that received FDA 510(k) clearance on 1988-01-12. The listed applicant is Spectramed, Inc.. The 510(k) number is K873168.

When did SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESS receive FDA 510(k) clearance?

SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESS received FDA 510(k) clearance on 1988-01-12, under 510(k) number K873168.

Who is the listed applicant for SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESS?

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

What is the FDA product code for SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESS?

The FDA product code for SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESS is DRS.

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Other records listing Spectramed, Inc. 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.

K896122AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPEDK892941CCO SYSTEM MODEL SP1467,SP5567,SP6267K895323MODEL DT-BAL, BALANCE SAVERK894362MODEL DT-IUPC2 TRANSDUCER TIPPED DUAL LUMEN IUPK881857AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU.K885235SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS.

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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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