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FDA 510(k)

ESA620 ELECTRICAL SAFETY ANALYZER

K-Number: K121722 · 2012-10-11

ApplicantFluke Biomedical
Decision Date2012-10-11
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ESA620 ELECTRICAL SAFETY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Fluke Biomedical. It received FDA 510(k) clearance on 2012-10-11 under 510(k) number K121722. 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 ESA620 ELECTRICAL SAFETY ANALYZER?

ESA620 ELECTRICAL SAFETY ANALYZER is a medical device that received FDA 510(k) clearance on 2012-10-11. The listed applicant is Fluke Biomedical. The 510(k) number is K121722.

When did ESA620 ELECTRICAL SAFETY ANALYZER receive FDA 510(k) clearance?

ESA620 ELECTRICAL SAFETY ANALYZER received FDA 510(k) clearance on 2012-10-11, under 510(k) number K121722.

Who is the listed applicant for ESA620 ELECTRICAL SAFETY ANALYZER?

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

What is the FDA product code for ESA620 ELECTRICAL SAFETY ANALYZER?

The FDA product code for ESA620 ELECTRICAL SAFETY ANALYZER 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 Fluke Biomedical 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.

K121860ESA615K110429PROSIM 4, PROSIM 6, PROSIM 8K103336MPS450 MULTIPARAMETER SIMULATORK083347IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADSK072114IMPULSE 6000D/7000DP

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.

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