Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ALLEN PRONE ARMBOARD

K-Number: K884838 · 1988-12-15

ApplicantEdgewater Medical Systems, Inc.
Decision Date1988-12-15
Product CodeBTX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ALLEN PRONE 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 1988-12-15 under 510(k) number K884838. 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 PRONE ARMBOARD?

ALLEN PRONE ARMBOARD is a medical device that received FDA 510(k) clearance on 1988-12-15. The listed applicant is Edgewater Medical Systems, Inc.. The 510(k) number is K884838.

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

ALLEN PRONE ARMBOARD received FDA 510(k) clearance on 1988-12-15, under 510(k) number K884838.

Who is the listed applicant for ALLEN PRONE 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 PRONE ARMBOARD?

The FDA product code for ALLEN PRONE 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.

K881292ALLEN LATERAL 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.K882524UNIVERSALLY ADJUSTABLE ARMBOARDKarlin Technology, Inc.K881292ALLEN LATERAL ARMBOARDEdgewater Medical Systems, 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.

↑