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FDA 510(k)

PHYSIOLOGICAL PRESS. TRANSDUCER PCM3630

K-Number: K823334 · 1983-03-24

ApplicantPsitron
Decision Date1983-03-24
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PHYSIOLOGICAL PRESS. TRANSDUCER PCM3630 is the device name listed in this FDA 510(k) record. The listed applicant is Psitron. It received FDA 510(k) clearance on 1983-03-24 under 510(k) number K823334. 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 PHYSIOLOGICAL PRESS. TRANSDUCER PCM3630?

PHYSIOLOGICAL PRESS. TRANSDUCER PCM3630 is a medical device that received FDA 510(k) clearance on 1983-03-24. The listed applicant is Psitron. The 510(k) number is K823334.

When did PHYSIOLOGICAL PRESS. TRANSDUCER PCM3630 receive FDA 510(k) clearance?

PHYSIOLOGICAL PRESS. TRANSDUCER PCM3630 received FDA 510(k) clearance on 1983-03-24, under 510(k) number K823334.

Who is the listed applicant for PHYSIOLOGICAL PRESS. TRANSDUCER PCM3630?

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

What is the FDA product code for PHYSIOLOGICAL PRESS. TRANSDUCER PCM3630?

The FDA product code for PHYSIOLOGICAL PRESS. TRANSDUCER PCM3630 is DRS.

Related Clinical Trials

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.

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Other records listing Psitron 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.

K781277STIMULATOR, NERVE, TRANSCUTANEOUS

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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