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)

FUKUDA DENSHI FX-302 AUTO/THREE CHAN

K-Number: K833594 · 1984-09-11

ApplicantBrentwood Instruments, Inc.
Decision Date1984-09-11
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FUKUDA DENSHI FX-302 AUTO/THREE CHAN is the device name listed in this FDA 510(k) record. The listed applicant is Brentwood Instruments, Inc.. It received FDA 510(k) clearance on 1984-09-11 under 510(k) number K833594. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUKUDA DENSHI FX-302 AUTO/THREE CHAN?

FUKUDA DENSHI FX-302 AUTO/THREE CHAN is a medical device that received FDA 510(k) clearance on 1984-09-11. The listed applicant is Brentwood Instruments, Inc.. The 510(k) number is K833594.

When did FUKUDA DENSHI FX-302 AUTO/THREE CHAN receive FDA 510(k) clearance?

FUKUDA DENSHI FX-302 AUTO/THREE CHAN received FDA 510(k) clearance on 1984-09-11, under 510(k) number K833594.

Who is the listed applicant for FUKUDA DENSHI FX-302 AUTO/THREE CHAN?

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

What is the FDA product code for FUKUDA DENSHI FX-302 AUTO/THREE CHAN?

The FDA product code for FUKUDA DENSHI FX-302 AUTO/THREE CHAN is DRT.

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 Brentwood Instruments, 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.

K896924SPIROSCAN 4000K882366RHYTHMSCAN HR HOLTER RECORDERK871572RHYTHMSCANK860024FUKUDA DENSHI CARDIMAX FCP-211K853979CARDIMAX FX-1164K854505CARDIMAX FX-406U

View all 21 devices →

Related Devices (Code: DRT)

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.

K254058DistaSense(TM) (v1)Life Detection TechnologiesK261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, Ltd.

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.

↑