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)

DISTENDER SERIES II BAROSTAT

K-Number: K991288 · 1999-06-08

ApplicantG & J Electronics, Inc.
Decision Date1999-06-08
Product CodeFFX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DISTENDER SERIES II BAROSTAT is the device name listed in this FDA 510(k) record. The listed applicant is G & J Electronics, Inc.. It received FDA 510(k) clearance on 1999-06-08 under 510(k) number K991288. The device is classified under product code FFX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISTENDER SERIES II BAROSTAT?

DISTENDER SERIES II BAROSTAT is a medical device that received FDA 510(k) clearance on 1999-06-08. The listed applicant is G & J Electronics, Inc.. The 510(k) number is K991288.

When did DISTENDER SERIES II BAROSTAT receive FDA 510(k) clearance?

DISTENDER SERIES II BAROSTAT received FDA 510(k) clearance on 1999-06-08, under 510(k) number K991288.

Who is the listed applicant for DISTENDER SERIES II BAROSTAT?

The FDA 510(k) record lists G & J Electronics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISTENDER SERIES II BAROSTAT?

The FDA product code for DISTENDER SERIES II BAROSTAT is FFX.

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 G & J Electronics, 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.

K973844GASTRIC AND RECTAL CATHETERS

Related Devices (Code: FFX)

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.

K252605mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)Medspira, LLCK240007Solar Compact (G4-1)Laborie Medical Technologies, Corp.K231861EndoflipTM 300 SystemCovidien, LLCK223705EndoflipTM 300Covidien, LLCK222000Transit-PelletsMedifactia ABK201106IntraMarX 3D Radiopaque MarkerAnx Robotica Corp

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.

↑