FDA 510(k)

EP-STAT

K-Number: K883152 · 1988-10-13

Decision Date1988-10-13

Product CodeDQK

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

EP-STAT is the device name listed in this FDA 510(k) record. The listed applicant is Coherent Systems, Inc.. It received FDA 510(k) clearance on 1988-10-13 under 510(k) number K883152. 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 EP-STAT?

EP-STAT is a medical device that received FDA 510(k) clearance on 1988-10-13. The listed applicant is Coherent Systems, Inc.. The 510(k) number is K883152.

When did EP-STAT receive FDA 510(k) clearance?

EP-STAT received FDA 510(k) clearance on 1988-10-13, under 510(k) number K883152.

Who is the listed applicant for EP-STAT?

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

What is the FDA product code for EP-STAT?

The FDA product code for EP-STAT is DQK.

Other records listing Coherent Systems, 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.

K932863E-FAX REMOTE MONITOR K932859E-FAX RECEIVER

Related Devices (Code: DQK)

K261729EnSite™ X EP SystemAbbott Medical K262005Affera Integrated Mapping SystemMedtronic, Inc.K253692AVVIGO™+ Multi-Modality Guidance SystemBoston Scientific K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott Medical K252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.