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FDA 510(k)

DANTEC UD 5500 MK2

K-Number: K913169 · 1992-01-23

ApplicantDantec Medical, Inc.
Decision Date1992-01-23
Product CodeFAP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DANTEC UD 5500 MK2 is the device name listed in this FDA 510(k) record. The listed applicant is Dantec Medical, Inc.. It received FDA 510(k) clearance on 1992-01-23 under 510(k) number K913169. 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 DANTEC UD 5500 MK2?

DANTEC UD 5500 MK2 is a medical device that received FDA 510(k) clearance on 1992-01-23. The listed applicant is Dantec Medical, Inc.. The 510(k) number is K913169.

When did DANTEC UD 5500 MK2 receive FDA 510(k) clearance?

DANTEC UD 5500 MK2 received FDA 510(k) clearance on 1992-01-23, under 510(k) number K913169.

Who is the listed applicant for DANTEC UD 5500 MK2?

The FDA 510(k) record lists Dantec Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DANTEC UD 5500 MK2?

The FDA product code for DANTEC UD 5500 MK2 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 Dantec Medical, 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.

K960503DANTEC DUETK950314DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19)K953999DANTEC DA CAPOK926363MULTI-DOP SK931801MULTI-DOP XK930458MULTI-DOP L

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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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