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)

SYNCHRONER TM (PROPOSED TRADENAME)

K-Number: K853350 · 1985-08-29

ApplicantFisons Corp.
Decision Date1985-08-29
Product CodeCCQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SYNCHRONER TM (PROPOSED TRADENAME) is the device name listed in this FDA 510(k) record. The listed applicant is Fisons Corp.. It received FDA 510(k) clearance on 1985-08-29 under 510(k) number K853350. The device is classified under product code CCQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNCHRONER TM (PROPOSED TRADENAME)?

SYNCHRONER TM (PROPOSED TRADENAME) is a medical device that received FDA 510(k) clearance on 1985-08-29. The listed applicant is Fisons Corp.. The 510(k) number is K853350.

When did SYNCHRONER TM (PROPOSED TRADENAME) receive FDA 510(k) clearance?

SYNCHRONER TM (PROPOSED TRADENAME) received FDA 510(k) clearance on 1985-08-29, under 510(k) number K853350.

Who is the listed applicant for SYNCHRONER TM (PROPOSED TRADENAME)?

The FDA 510(k) record lists Fisons Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNCHRONER TM (PROPOSED TRADENAME)?

The FDA product code for SYNCHRONER TM (PROPOSED TRADENAME) is CCQ.

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 Fisons Corp. 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.

K950206FISONEB(R) IIK771679MICROFLATOR

Related Devices (Code: CCQ)

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.

K972397EZ SPRAYIntertex Research, Inc.K964956E-Z SPACER MASK (SMALL)Airpharma, LLCK961894MDI TUTORMdi Tutor, Inc.K961455MEDSHIELD/AEROCHAMBERDiemolding Corp.K960593SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100Aradigm Corp.K922033SALINE SOLUTION- STERILETrinity Laboratories, 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.

↑