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FDA 510(k)

MODEL 1350 URODYNAMIC WAVEFORM PROCESSOR

K-Number: K863167 · 1986-10-24

ApplicantLife-Tech Intl., Inc.
Decision Date1986-10-24
Product CodeFAP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODEL 1350 URODYNAMIC WAVEFORM PROCESSOR is the device name listed in this FDA 510(k) record. The listed applicant is Life-Tech Intl., Inc.. It received FDA 510(k) clearance on 1986-10-24 under 510(k) number K863167. The device is classified under product code FAP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 1350 URODYNAMIC WAVEFORM PROCESSOR?

MODEL 1350 URODYNAMIC WAVEFORM PROCESSOR is a medical device that received FDA 510(k) clearance on 1986-10-24. The listed applicant is Life-Tech Intl., Inc.. The 510(k) number is K863167.

When did MODEL 1350 URODYNAMIC WAVEFORM PROCESSOR receive FDA 510(k) clearance?

MODEL 1350 URODYNAMIC WAVEFORM PROCESSOR received FDA 510(k) clearance on 1986-10-24, under 510(k) number K863167.

Who is the listed applicant for MODEL 1350 URODYNAMIC WAVEFORM PROCESSOR?

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

What is the FDA product code for MODEL 1350 URODYNAMIC WAVEFORM PROCESSOR?

The FDA product code for MODEL 1350 URODYNAMIC WAVEFORM PROCESSOR is FAP.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Life-Tech Intl., 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.

K001129PROLONG, MODELS PL50, PL100, PL150K955031MAXISTIMK954505EZ STIMK954315PVC ABDOMINAL/RECTAL PRESSURE CATHETERK954341URODYNAMICS TUBING AND INFUSION SETSK953451UROPUMP TUBE & DAMPING CHAMGER

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Related Devices (Code: FAP)

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.

K113771SIGNAL GEAR URETHRAL CATHETER ELECTRODENeurovision Medical Products, Inc.K974775SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGEAirtronic Services, Inc.K963330URODYNAMIC ANALYSIS MODULESynectics Medical, Inc.K962472RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETERRusch Intl.K931175SCHUSTER DISPOSABLE BALLOON PROBESandhill Scientific, Inc.K931179UROLAB SPECTRUMLife-Tech Intl., 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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