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)

SYNEFLASH & SYNEVIEW

K-Number: K990727 · 1999-11-26

ApplicantEla Medical, Inc.
Decision Date1999-11-26
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SYNEFLASH & SYNEVIEW is the device name listed in this FDA 510(k) record. The listed applicant is Ela Medical, Inc.. It received FDA 510(k) clearance on 1999-11-26 under 510(k) number K990727. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNEFLASH & SYNEVIEW?

SYNEFLASH & SYNEVIEW is a medical device that received FDA 510(k) clearance on 1999-11-26. The listed applicant is Ela Medical, Inc.. The 510(k) number is K990727.

When did SYNEFLASH & SYNEVIEW receive FDA 510(k) clearance?

SYNEFLASH & SYNEVIEW received FDA 510(k) clearance on 1999-11-26, under 510(k) number K990727.

Who is the listed applicant for SYNEFLASH & SYNEVIEW?

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

What is the FDA product code for SYNEFLASH & SYNEVIEW?

The FDA product code for SYNEFLASH & SYNEVIEW is DQK.

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 Ela 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.

K042002SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADERK032466SPIDERVIEWK002817SYNETECK993448STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADSK000029STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADSK972574STELA MODEL UJ45 PACING LEADS

View all 43 devices →

Related Devices (Code: DQK)

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.

K261729EnSite™ X EP SystemAbbott MedicalK262005Affera Integrated Mapping SystemMedtronic, Inc.K253692AVVIGO™+ Multi-Modality Guidance SystemBoston ScientificK253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC

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.

↑