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FDA 510(k)

UROLAB SPECTRUM

K-Number: K931179 · 1993-11-18

ApplicantLife-Tech Intl., Inc.
Decision Date1993-11-18
Product CodeFAP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UROLAB SPECTRUM 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 1993-11-18 under 510(k) number K931179. 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 UROLAB SPECTRUM?

UROLAB SPECTRUM is a medical device that received FDA 510(k) clearance on 1993-11-18. The listed applicant is Life-Tech Intl., Inc.. The 510(k) number is K931179.

When did UROLAB SPECTRUM receive FDA 510(k) clearance?

UROLAB SPECTRUM received FDA 510(k) clearance on 1993-11-18, under 510(k) number K931179.

Who is the listed applicant for UROLAB SPECTRUM?

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 UROLAB SPECTRUM?

The FDA product code for UROLAB SPECTRUM 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.

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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.K922476URO-PRO 2000Fiberoptic 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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