FDA 510(k)

Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers

K-번호: K160442 · 2016-10-21

결정일2016-10-21

제품 코드IYN

자문 위원회RA

결정Substantially Equivalent

기기 요약

Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers is the device name listed in this FDA 510(k) record. The listed applicant is Neural Analytics, Inc.. It received FDA 510(k) clearance on 2016-10-21 under 510(k) number K160442. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers?

Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers is a medical device that received FDA 510(k) clearance on 2016-10-21. The listed applicant is Neural Analytics, Inc.. The 510(k) number is K160442.

When did Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers receive FDA 510(k) clearance?

Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers received FDA 510(k) clearance on 2016-10-21, under 510(k) number K160442.

Who is the listed applicant for Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers?

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

What is the FDA product code for Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers?

The FDA product code for Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers is IYN.

Neural Analytics, Inc.를 신청인으로 등재한 기타 기록

K180455NeuralBot

관련 기기 (코드: IYN)

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.