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FDA 510(k)

URODYNAMIC INSTRUMENTS

K-Number: K770897 · 1977-06-03

ApplicantLife-Tech Instruments, Inc.
Decision Date1977-06-03
Product CodeEXY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URODYNAMIC INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Life-Tech Instruments, Inc.. It received FDA 510(k) clearance on 1977-06-03 under 510(k) number K770897. 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 URODYNAMIC INSTRUMENTS?

URODYNAMIC INSTRUMENTS is a medical device that received FDA 510(k) clearance on 1977-06-03. The listed applicant is Life-Tech Instruments, Inc.. The 510(k) number is K770897.

When did URODYNAMIC INSTRUMENTS receive FDA 510(k) clearance?

URODYNAMIC INSTRUMENTS received FDA 510(k) clearance on 1977-06-03, under 510(k) number K770897.

Who is the listed applicant for URODYNAMIC INSTRUMENTS?

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

What is the FDA product code for URODYNAMIC INSTRUMENTS?

The FDA product code for URODYNAMIC INSTRUMENTS is EXY.

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Other records listing Life-Tech Instruments, 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.

K812177LIFE-TECH #1857 PRESSURE/POLOT MODULEK812179LIFE-TECH #1753 BIOFEEDBACK TRAINERK812180LIFE-TECH #5102 VISULABK812178LIFE-TECH #'S 1106/1156 UROLABSK800112AMBLYOPIA TRAINERK790663MODEL 1750 STANDING URINAL

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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

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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