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FDA 510(k)

13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE

K-Number: K874759 · 1988-04-14

ApplicantDantec Electronics, Inc.
Decision Date1988-04-14
Product CodeFAP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE is the device name listed in this FDA 510(k) record. The listed applicant is Dantec Electronics, Inc.. It received FDA 510(k) clearance on 1988-04-14 under 510(k) number K874759. 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 13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE?

13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE is a medical device that received FDA 510(k) clearance on 1988-04-14. The listed applicant is Dantec Electronics, Inc.. The 510(k) number is K874759.

When did 13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE receive FDA 510(k) clearance?

13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE received FDA 510(k) clearance on 1988-04-14, under 510(k) number K874759.

Who is the listed applicant for 13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE?

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

What is the FDA product code for 13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE?

The FDA product code for 13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE is FAP.

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Other records listing Dantec Electronics, 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.

K895460CONCENTRIC ELECTRODE TYPE #13R01, 13R02K894911SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118K884915DANTEC 22K60/61/62 CATHETER TIP TRANSDUCERK881915DANTEC MAGNETIC STIMULATORK874758DANTEC 13L40 ST. MARKS'S PUDENDAL ELECTRODEK874735DANTEC 13L35/36/37 STIM. AND RECORDING ELECTRODE

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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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