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)

BEDSIDE BUTLER

K-Number: K944345 · 1994-10-17

ApplicantTrac Medical, Inc.
Decision Date1994-10-17
Product CodeIQA
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BEDSIDE BUTLER is the device name listed in this FDA 510(k) record. The listed applicant is Trac Medical, Inc.. It received FDA 510(k) clearance on 1994-10-17 under 510(k) number K944345. The device is classified under product code IQA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BEDSIDE BUTLER?

BEDSIDE BUTLER is a medical device that received FDA 510(k) clearance on 1994-10-17. The listed applicant is Trac Medical, Inc.. The 510(k) number is K944345.

When did BEDSIDE BUTLER receive FDA 510(k) clearance?

BEDSIDE BUTLER received FDA 510(k) clearance on 1994-10-17, under 510(k) number K944345.

Who is the listed applicant for BEDSIDE BUTLER?

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

What is the FDA product code for BEDSIDE BUTLER?

The FDA product code for BEDSIDE BUTLER is IQA.

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 Trac Medical, 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.

K933431ORTHOTRAC COAXIAL LASER

Related Devices (Code: IQA)

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.

K961306DELTATALKER WITH INFRAREDPrentke Romich Co.K953905IMPERIUMTeledyne Brown EngineeringK953937LIAISON COMPUTER ACCESS & ENVIRONMENTAL CONTROL SYSTEMApt Technology, Inc.K943244DEUCEApt Technology, Inc.K944585SCANNING DIRECTORPrentke Romich Co.K940223LEARN MODE WATERPROOF PENDANT PANIC BUTTONInteractive Technologies, 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.

↑