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FDA 510(k)

MAXI-FLOW

K-Number: K955150 · 1996-01-23

ApplicantBio-Medical Devices, Inc.
Decision Date1996-01-23
Product CodeBYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MAXI-FLOW is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Medical Devices, Inc.. It received FDA 510(k) clearance on 1996-01-23 under 510(k) number K955150. The device is classified under product code BYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAXI-FLOW?

MAXI-FLOW is a medical device that received FDA 510(k) clearance on 1996-01-23. The listed applicant is Bio-Medical Devices, Inc.. The 510(k) number is K955150.

When did MAXI-FLOW receive FDA 510(k) clearance?

MAXI-FLOW received FDA 510(k) clearance on 1996-01-23, under 510(k) number K955150.

Who is the listed applicant for MAXI-FLOW?

The FDA 510(k) record lists Bio-Medical Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAXI-FLOW?

The FDA product code for MAXI-FLOW is BYY.

Other records listing Bio-Medical Devices, 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.

K040485MAXAIR SURGICAL HELMET SYSTEMK981888SMOKE-EVACK955149MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REELK955151MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATORK940156THE REEL THINGK933742TOP GUN

View all 7 devices →

Related Devices (Code: BYY)

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.

K960616VITAFLOW SUCTION/ASPIRATION TUBING SETVital Concepts, Inc.K960218CONNECTING TUBINGCustom Pack ReliabilityK955149MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REELBio-Medical Devices, Inc.K955151MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATORBio-Medical Devices, Inc.K922989WILTEK IRRIGAITON/ASPIRATION TUBE SETWiltek Medical, Inc.K911586GENERAL HOSPITAL TUBING CLAMP (NON-ELECTRIC)Megadyne Medical Products, 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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