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FDA 510(k)

ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM

K-Number: K963064 · 1997-06-05

ApplicantLaborie Medical Tech Corp.
Decision Date1997-06-05
Product CodeFFX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM is the device name listed in this FDA 510(k) record. The listed applicant is Laborie Medical Tech Corp.. It received FDA 510(k) clearance on 1997-06-05 under 510(k) number K963064. 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 ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM?

ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM is a medical device that received FDA 510(k) clearance on 1997-06-05. The listed applicant is Laborie Medical Tech Corp.. The 510(k) number is K963064.

When did ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM receive FDA 510(k) clearance?

ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM received FDA 510(k) clearance on 1997-06-05, under 510(k) number K963064.

Who is the listed applicant for ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM?

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

What is the FDA product code for ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM?

The FDA product code for ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM is FFX.

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 Laborie Medical Tech Corp. 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.

K993721UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBESK990041UROSTYM BIOFEEDBACK AND STIMULATION PROBESK991479VISER PENILE TUMESCENCE MONITORK950016CART, MODE NUMBER UDS-CART

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

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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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