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FDA 510(k)

ALLEN LATERAL ARMBOARD

K-Number: K881292 · 1988-04-07

ApplicantEdgewater Medical Systems, Inc.
Decision Date1988-04-07
Product CodeBTX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ALLEN LATERAL ARMBOARD is the device name listed in this FDA 510(k) record. The listed applicant is Edgewater Medical Systems, Inc.. It received FDA 510(k) clearance on 1988-04-07 under 510(k) number K881292. 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 ALLEN LATERAL ARMBOARD?

ALLEN LATERAL ARMBOARD is a medical device that received FDA 510(k) clearance on 1988-04-07. The listed applicant is Edgewater Medical Systems, Inc.. The 510(k) number is K881292.

When did ALLEN LATERAL ARMBOARD receive FDA 510(k) clearance?

ALLEN LATERAL ARMBOARD received FDA 510(k) clearance on 1988-04-07, under 510(k) number K881292.

Who is the listed applicant for ALLEN LATERAL ARMBOARD?

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

What is the FDA product code for ALLEN LATERAL ARMBOARD?

The FDA product code for ALLEN LATERAL ARMBOARD 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Edgewater Medical Systems, 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.

K884838ALLEN PRONE ARMBOARD

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.K864670BOARD, ARM (WITH COVER)Anago, 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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