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FDA 510(k)

UROPUMP MODEL 1711

K-Number: K843224 · 1984-10-19

ApplicantLife-Tech Intl., Inc.
Decision Date1984-10-19
Product CodeFFG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UROPUMP MODEL 1711 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 1984-10-19 under 510(k) number K843224. The device is classified under product code FFG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UROPUMP MODEL 1711?

UROPUMP MODEL 1711 is a medical device that received FDA 510(k) clearance on 1984-10-19. The listed applicant is Life-Tech Intl., Inc.. The 510(k) number is K843224.

When did UROPUMP MODEL 1711 receive FDA 510(k) clearance?

UROPUMP MODEL 1711 received FDA 510(k) clearance on 1984-10-19, under 510(k) number K843224.

Who is the listed applicant for UROPUMP MODEL 1711?

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 UROPUMP MODEL 1711?

The FDA product code for UROPUMP MODEL 1711 is FFG.

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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, PL150K954505EZ STIMK955031MAXISTIMK954315PVC ABDOMINAL/RECTAL PRESSURE CATHETERK954341URODYNAMICS TUBING AND INFUSION SETSK953451UROPUMP TUBE & DAMPING CHAMGER

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Related Devices (Code: FFG)

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.

K893827PEAK FLOW RATE METERLaytech Medical Co.K883274SURGITEK (R) UROFLOW SYSTEMMedical Engineering Corp.K850169ERIS URO-DIAGNOSTIC SYSTEMEris Medical TechnologyK8443381URO-LOG HOME DIAGNOSTIC PACKEpcom Medical Systems, Inc.K843441URINARY DRAINAGE CONTAINER 2012-WITHVital Metrics, Inc.K843442URINARY DRAINAGE CONTAINER 2013 WITHVital Metrics, 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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