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FDA 510(k)

LABORIE FIBEROPTIC PRESSURE SENSOR & INTERFACE

K-Number: K853059 · 1986-01-10

ApplicantTridak Division of Indicon, Inc.
Decision Date1986-01-10
Product CodeFAP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LABORIE FIBEROPTIC PRESSURE SENSOR & INTERFACE is the device name listed in this FDA 510(k) record. The listed applicant is Tridak Division of Indicon, Inc.. It received FDA 510(k) clearance on 1986-01-10 under 510(k) number K853059. 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 LABORIE FIBEROPTIC PRESSURE SENSOR & INTERFACE?

LABORIE FIBEROPTIC PRESSURE SENSOR & INTERFACE is a medical device that received FDA 510(k) clearance on 1986-01-10. The listed applicant is Tridak Division of Indicon, Inc.. The 510(k) number is K853059.

When did LABORIE FIBEROPTIC PRESSURE SENSOR & INTERFACE receive FDA 510(k) clearance?

LABORIE FIBEROPTIC PRESSURE SENSOR & INTERFACE received FDA 510(k) clearance on 1986-01-10, under 510(k) number K853059.

Who is the listed applicant for LABORIE FIBEROPTIC PRESSURE SENSOR & INTERFACE?

The FDA 510(k) record lists Tridak Division of Indicon, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LABORIE FIBEROPTIC PRESSURE SENSOR & INTERFACE?

The FDA product code for LABORIE FIBEROPTIC PRESSURE SENSOR & INTERFACE is FAP.

Related Clinical Trials

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Other records listing Tridak Division of Indicon, 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.

K891007NONIMPLANTED ELECTRICAL CONTINENCE DEVICEK860744OPTHALMIC SURGICAL INSTRUMENTSK852856LABORIE URODYNAMICS PROCESSORK851934CYTOLOGICAL CERVICAL SPATULA THE MULTI-SPATULAK842609R.L. MEDICAL TWIN LIGHT SOURCEK840605LABORIE FIBREOPTIC LIGHT CABLE

View all 7 devices →

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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