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FDA 510(k)

THE KENDALL URINARY OUTPUT MONITOR

K-Number: K852083 · 1985-09-20

ApplicantThe Kendal Co.
Decision Date1985-09-20
Product CodeFFO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

THE KENDALL URINARY OUTPUT MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is The Kendal Co.. It received FDA 510(k) clearance on 1985-09-20 under 510(k) number K852083. 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 THE KENDALL URINARY OUTPUT MONITOR?

THE KENDALL URINARY OUTPUT MONITOR is a medical device that received FDA 510(k) clearance on 1985-09-20. The listed applicant is The Kendal Co.. The 510(k) number is K852083.

When did THE KENDALL URINARY OUTPUT MONITOR receive FDA 510(k) clearance?

THE KENDALL URINARY OUTPUT MONITOR received FDA 510(k) clearance on 1985-09-20, under 510(k) number K852083.

Who is the listed applicant for THE KENDALL URINARY OUTPUT MONITOR?

The FDA 510(k) record lists The Kendal Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE KENDALL URINARY OUTPUT MONITOR?

The FDA product code for THE KENDALL URINARY OUTPUT MONITOR is FFO.

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Other records listing The Kendal Co. 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.

K000087MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FRK990500KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946CK991758MONOJECT INSULIN SYRINGEK970969KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SETK951488KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAPK942664KENDALL MODEL 6325 SCD SEQUEL COMPRESSION SYSTEM

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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.K860368URDYN 5000 (UROFLOWMETER)Dantec Electronics, Inc.K853119URODYN 1000Dantec Electronics, 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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