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FDA 510(k)

GAELTEC MPR SERIES

K-Number: K921062 · 1992-07-30

ApplicantMedical Measurements, Inc.
Decision Date1992-07-30
Product CodeFFX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GAELTEC MPR SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Medical Measurements, Inc.. It received FDA 510(k) clearance on 1992-07-30 under 510(k) number K921062. The device is classified under product code FFX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAELTEC MPR SERIES?

GAELTEC MPR SERIES is a medical device that received FDA 510(k) clearance on 1992-07-30. The listed applicant is Medical Measurements, Inc.. The 510(k) number is K921062.

When did GAELTEC MPR SERIES receive FDA 510(k) clearance?

GAELTEC MPR SERIES received FDA 510(k) clearance on 1992-07-30, under 510(k) number K921062.

Who is the listed applicant for GAELTEC MPR SERIES?

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

What is the FDA product code for GAELTEC MPR SERIES?

The FDA product code for GAELTEC MPR SERIES is FFX.

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Other records listing Medical Measurements, 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.

K902097MODEL TR RECTAL SUCTION BIOPSY TUBEK863479MODIFIED ICT/B INTRACRANIAL PRESS. TRANS. EPIDURALK801757MMI/GAELTEC CATHETER TIP PRESS. TRANSDUK801756MMI/GAELTEC CATHETER TIP TRANSDUCK801880MMI/GAELTEC SERIES 8T DIFF. PRESS. TRANSK801758MMI/GAELTEC CATHETER INTRAUTERINE

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Related Devices (Code: FFX)

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.

K252605mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)Medspira, LLCK240007Solar Compact (G4-1)Laborie Medical Technologies, Corp.K231861EndoflipTM 300 SystemCovidien, LLCK223705EndoflipTM 300Covidien, LLCK222000Transit-PelletsMedifactia ABK201106IntraMarX 3D Radiopaque MarkerAnx Robotica Corp

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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