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FDA 510(k)

UORCAP,MODEL NUMBER UDS-UCAP

K-Number: K941105 · 1994-05-10

ApplicantLaborie Medical Tech, Inc.
Decision Date1994-05-10
Product CodeEXY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UORCAP,MODEL NUMBER UDS-UCAP is the device name listed in this FDA 510(k) record. The listed applicant is Laborie Medical Tech, Inc.. It received FDA 510(k) clearance on 1994-05-10 under 510(k) number K941105. The device is classified under product code EXY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UORCAP,MODEL NUMBER UDS-UCAP?

UORCAP,MODEL NUMBER UDS-UCAP is a medical device that received FDA 510(k) clearance on 1994-05-10. The listed applicant is Laborie Medical Tech, Inc.. The 510(k) number is K941105.

When did UORCAP,MODEL NUMBER UDS-UCAP receive FDA 510(k) clearance?

UORCAP,MODEL NUMBER UDS-UCAP received FDA 510(k) clearance on 1994-05-10, under 510(k) number K941105.

Who is the listed applicant for UORCAP,MODEL NUMBER UDS-UCAP?

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

What is the FDA product code for UORCAP,MODEL NUMBER UDS-UCAP?

The FDA product code for UORCAP,MODEL NUMBER UDS-UCAP is EXY.

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Related Devices (Code: EXY)

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.

K022721UROPOWERW.O.M. World of Medicine AGK971913GR100F URINE FLOWMETERAlbyn Medical , Ltd.K953999DANTEC DA CAPODantec Medical, Inc.K951442FLOLABSynectics Medical, Inc.K944972URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRYMyo/Kinetic Systems, Inc.K9454954-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTIONFiberoptic Sensor Technlogies, Inc.

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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