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FDA 510(k)

HYDROTRACK

K-Number: K935509 · 1994-10-03

ApplicantFerno Ille
Decision Date1994-10-03
Product CodeBXB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HYDROTRACK is the device name listed in this FDA 510(k) record. The listed applicant is Ferno Ille. It received FDA 510(k) clearance on 1994-10-03 under 510(k) number K935509. The device is classified under product code BXB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDROTRACK?

HYDROTRACK is a medical device that received FDA 510(k) clearance on 1994-10-03. The listed applicant is Ferno Ille. The 510(k) number is K935509.

When did HYDROTRACK receive FDA 510(k) clearance?

HYDROTRACK received FDA 510(k) clearance on 1994-10-03, under 510(k) number K935509.

Who is the listed applicant for HYDROTRACK?

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

What is the FDA product code for HYDROTRACK?

The FDA product code for HYDROTRACK is BXB.

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Related Devices (Code: BXB)

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.

K072887G-TRAINER MEDICALAlter-G, Inc.K003272FLO-BOOTDiscovery Group, LLCK952975ANKLE CALF EXERCISER PHLEBOPUMPPrevent Products, Inc.K953456E-Z FLEXFluid Motion Biotechnologies, Inc.K955105BTE CPM-10Baltimore Therapeutic Equipment Co.K955106BTE CPM-20Baltimore Therapeutic Equipment 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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