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FDA 510(k)

UROVISION JANUS

K-Number: K953353 · 1995-09-08

ApplicantLife-Tech Intl., Inc.
Decision Date1995-09-08
Product CodeFEN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UROVISION JANUS 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 1995-09-08 under 510(k) number K953353. The device is classified under product code FEN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UROVISION JANUS?

UROVISION JANUS is a medical device that received FDA 510(k) clearance on 1995-09-08. The listed applicant is Life-Tech Intl., Inc.. The 510(k) number is K953353.

When did UROVISION JANUS receive FDA 510(k) clearance?

UROVISION JANUS received FDA 510(k) clearance on 1995-09-08, under 510(k) number K953353.

Who is the listed applicant for UROVISION JANUS?

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 UROVISION JANUS?

The FDA product code for UROVISION JANUS is FEN.

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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: FEN)

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.

K212830CT3000ProSrs MedicalK082701URONIRS, MODEL 2000Urodynamix Technologies, Ltd.K073552LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORYLaborie Medical Technologies, Corp.K001386ACCUSET SENSOR, MODEL 2000Pelvicare, Inc.K992715NEURO URODYNAMIC SUITE, MODEL 9032E0101Medtronic Functional Diagnostics A/SK983325IN-PROBE II URODYNAMIC SYSTEMInfluence, 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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