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FDA 510(k)

EDAC QUANTIFIER

K-Number: K071231 · 2007-05-17

ApplicantLuna Innovations, Inc.
Decision Date2007-05-17
Product CodeKRL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EDAC QUANTIFIER is the device name listed in this FDA 510(k) record. The listed applicant is Luna Innovations, Inc.. It received FDA 510(k) clearance on 2007-05-17 under 510(k) number K071231. The device is classified under product code KRL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EDAC QUANTIFIER?

EDAC QUANTIFIER is a medical device that received FDA 510(k) clearance on 2007-05-17. The listed applicant is Luna Innovations, Inc.. The 510(k) number is K071231.

When did EDAC QUANTIFIER receive FDA 510(k) clearance?

EDAC QUANTIFIER received FDA 510(k) clearance on 2007-05-17, under 510(k) number K071231.

Who is the listed applicant for EDAC QUANTIFIER?

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

What is the FDA product code for EDAC QUANTIFIER?

The FDA product code for EDAC QUANTIFIER is KRL.

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Related Devices (Code: KRL)

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.

K103469STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05Sorin Group Deutschland GmbHK090698CAPIOX BUBBLE TRAP WITH X-COATINGTerumo Cardiovascular SystemsK961364AUTOMATIC TUBING CLAMP SYSTEM (ATC)Rocky Mountain Research, Inc.K961598ELS AUTOMATIC TUBING CLAMP SYSTEMRocky Mountain Research, Inc.K940651SARNS ULTRASONIC AIR SENSOR3M Health Care, SarnsK935977SARNS AIR DETECTION SYSTEM3M Health Care, Sarns

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.

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