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FDA 510(k)

BOARD, ARM (WITH COVER)

K-Number: K864670 · 1987-01-12

ApplicantAnago, Inc.
Decision Date1987-01-12
Product CodeBTX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BOARD, ARM (WITH COVER) is the device name listed in this FDA 510(k) record. The listed applicant is Anago, Inc.. It received FDA 510(k) clearance on 1987-01-12 under 510(k) number K864670. 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 BOARD, ARM (WITH COVER)?

BOARD, ARM (WITH COVER) is a medical device that received FDA 510(k) clearance on 1987-01-12. The listed applicant is Anago, Inc.. The 510(k) number is K864670.

When did BOARD, ARM (WITH COVER) receive FDA 510(k) clearance?

BOARD, ARM (WITH COVER) received FDA 510(k) clearance on 1987-01-12, under 510(k) number K864670.

Who is the listed applicant for BOARD, ARM (WITH COVER)?

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

What is the FDA product code for BOARD, ARM (WITH COVER)?

The FDA product code for BOARD, ARM (WITH COVER) is BTX.

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Other records listing Anago, 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.

K925659U.C.E.Z. LENS CLEANER KITK930161ANAGO SPINAL ANESTHESIA TRAYK926137ANAGO FEM-COOL/FEM-COOL PETITEK926589ANAGO WARM PACKK926590ANAGO DISPOSABLE INSTANT COLD PACKK920615ANAGO CONTINUOUS EPIDURAL ANESTHESIA TRAY/KIT

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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.K833664ARMBOARD AND THE BOARDRick Robbin & Frederick Auerbach

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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