FDA 510(k)

ESA615

K-Number: K121860 · 2013-01-25

Decision Date2013-01-25

Product CodeDRT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ESA615 is the device name listed in this FDA 510(k) record. The listed applicant is Fluke Biomedical. It received FDA 510(k) clearance on 2013-01-25 under 510(k) number K121860. 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 ESA615?

ESA615 is a medical device that received FDA 510(k) clearance on 2013-01-25. The listed applicant is Fluke Biomedical. The 510(k) number is K121860.

When did ESA615 receive FDA 510(k) clearance?

ESA615 received FDA 510(k) clearance on 2013-01-25, under 510(k) number K121860.

Who is the listed applicant for ESA615?

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 ESA615?

The FDA product code for ESA615 is DRT.

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.

K121722ESA620 ELECTRICAL SAFETY ANALYZER K110429PROSIM 4, PROSIM 6, PROSIM 8 K103336MPS450 MULTIPARAMETER SIMULATOR K083347IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS K072114IMPULSE 6000D/7000DP

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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.