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)

4/1 ARMBOARD

K-Number: K900175 · 1990-01-24

ApplicantInfection Control Products, Inc.
Decision Date1990-01-24
Product CodeBTX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

4/1 ARMBOARD is the device name listed in this FDA 510(k) record. The listed applicant is Infection Control Products, Inc.. It received FDA 510(k) clearance on 1990-01-24 under 510(k) number K900175. 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 4/1 ARMBOARD?

4/1 ARMBOARD is a medical device that received FDA 510(k) clearance on 1990-01-24. The listed applicant is Infection Control Products, Inc.. The 510(k) number is K900175.

When did 4/1 ARMBOARD receive FDA 510(k) clearance?

4/1 ARMBOARD received FDA 510(k) clearance on 1990-01-24, under 510(k) number K900175.

Who is the listed applicant for 4/1 ARMBOARD?

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

What is the FDA product code for 4/1 ARMBOARD?

The FDA product code for 4/1 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 Infection Control Products, 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.

K935779AGAFAR FACE SHIELDK900643FLUID SOAKERSHIELDK900644I.V. FREEDOM CLIP

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.K884838ALLEN PRONE ARMBOARDEdgewater Medical Systems, 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.

↑