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FDA 510(k)

HOME URODATA SYSTEM(TM)

K-Number: K900770 · 1990-06-08

ApplicantBiodan Medical Systems, Ltd.
Decision Date1990-06-08
Product CodeEXY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HOME URODATA SYSTEM(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Biodan Medical Systems, Ltd.. It received FDA 510(k) clearance on 1990-06-08 under 510(k) number K900770. The device is classified under product code EXY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOME URODATA SYSTEM(TM)?

HOME URODATA SYSTEM(TM) is a medical device that received FDA 510(k) clearance on 1990-06-08. The listed applicant is Biodan Medical Systems, Ltd.. The 510(k) number is K900770.

When did HOME URODATA SYSTEM(TM) receive FDA 510(k) clearance?

HOME URODATA SYSTEM(TM) received FDA 510(k) clearance on 1990-06-08, under 510(k) number K900770.

Who is the listed applicant for HOME URODATA SYSTEM(TM)?

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

What is the FDA product code for HOME URODATA SYSTEM(TM)?

The FDA product code for HOME URODATA SYSTEM(TM) is EXY.

Related Clinical Trials

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Other records listing Biodan Medical Systems, Ltd. 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.

K932153THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROMEK930261RTM REHABILITATION TREADMILL, MODEL #945-200K930262TREATMENT TABLE, MODEL #825-100K930259TRACTION TABLE MODEL #825-200K926083NUCLEAR PATIENT SANNING TABLES, VARIOUS TYPESK926082CARDIAC STRESS TABLE, 056-180/UNIV ROLL STRESS ATT

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Related Devices (Code: EXY)

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.

K022721UROPOWERW.O.M. World of Medicine AGK971913GR100F URINE FLOWMETERAlbyn Medical , Ltd.K953999DANTEC DA CAPODantec Medical, Inc.K951442FLOLABSynectics Medical, Inc.K944972URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRYMyo/Kinetic Systems, Inc.K9454954-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTIONFiberoptic Sensor Technlogies, 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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