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FDA 510(k)

URDYN 5000 (UROFLOWMETER)

K-Number: K860368 · 1986-04-23

ApplicantDantec Electronics, Inc.
Decision Date1986-04-23
Product CodeFFO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URDYN 5000 (UROFLOWMETER) 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 1986-04-23 under 510(k) number K860368. The device is classified under product code FFO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URDYN 5000 (UROFLOWMETER)?

URDYN 5000 (UROFLOWMETER) is a medical device that received FDA 510(k) clearance on 1986-04-23. The listed applicant is Dantec Electronics, Inc.. The 510(k) number is K860368.

When did URDYN 5000 (UROFLOWMETER) receive FDA 510(k) clearance?

URDYN 5000 (UROFLOWMETER) received FDA 510(k) clearance on 1986-04-23, under 510(k) number K860368.

Who is the listed applicant for URDYN 5000 (UROFLOWMETER)?

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 URDYN 5000 (UROFLOWMETER)?

The FDA product code for URDYN 5000 (UROFLOWMETER) is FFO.

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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 ELECTRODEK87475913L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE

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Related Devices (Code: FFO)

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.

K993544SPACE-OR RETRACTORAdvanced Surgical Concepts (Asc)K870897KODNER ANAL PERIONEAL RETRACTORSur-Med Instruments, Inc.K853119URODYN 1000Dantec Electronics, Inc.K852083THE KENDALL URINARY OUTPUT MONITORThe Kendal Co.

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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