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FDA 510(k)

IV ARMBOARDS

K-Number: K781233 · 1978-08-14

ApplicantFibre Formations, Inc.
Decision Date1978-08-14
Product CodeBTX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IV ARMBOARDS is the device name listed in this FDA 510(k) record. The listed applicant is Fibre Formations, Inc.. It received FDA 510(k) clearance on 1978-08-14 under 510(k) number K781233. The device is classified under product code BTX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IV ARMBOARDS?

IV ARMBOARDS is a medical device that received FDA 510(k) clearance on 1978-08-14. The listed applicant is Fibre Formations, Inc.. The 510(k) number is K781233.

When did IV ARMBOARDS receive FDA 510(k) clearance?

IV ARMBOARDS received FDA 510(k) clearance on 1978-08-14, under 510(k) number K781233.

Who is the listed applicant for IV ARMBOARDS?

The FDA 510(k) record lists Fibre Formations, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IV ARMBOARDS?

The FDA product code for IV ARMBOARDS is BTX.

Related Clinical Trials

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.

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Other records listing Fibre Formations, 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.

K791709HEEL/ELBOW PROTECTORSK790922DISPOSABLE ADULT DIAPERK781930PANT LINER, DISP. INCONTINENTK781246FOAM COMFORT RINGS

Related Devices (Code: BTX)

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.

K935098BABY BOARDSentry Medical Products, Inc.K9001754/1 ARMBOARDInfection Control Products, Inc.K884838ALLEN PRONE ARMBOARDEdgewater Medical Systems, Inc.K882524UNIVERSALLY ADJUSTABLE ARMBOARDKarlin Technology, Inc.K881292ALLEN LATERAL ARMBOARDEdgewater Medical Systems, Inc.K864670BOARD, ARM (WITH COVER)Anago, 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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