FDA 510(k)

SACCADOMETER PLUS, SACCADOMETER ADVANCED

K-번호: K152890 · 2016-08-11

결정일2016-08-11

제품 코드HLL

자문 위원회의료장비 규제 텍스트 번역 OP

결정대체적으로 동일

기기 요약

SACCADOMETER PLUS, SACCADOMETER ADVANCED is the device name listed in this FDA 510(k) record. The listed applicant is Ober Consulting Sp. Z.O.O.. It received FDA 510(k) clearance on 2016-08-11 under 510(k) number K152890. The device is classified under product code HLL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the SACCADOMETER PLUS, SACCADOMETER ADVANCED?

SACCADOMETER PLUS, SACCADOMETER ADVANCED is a medical device that received FDA 510(k) clearance on 2016-08-11. The listed applicant is Ober Consulting Sp. Z.O.O.. The 510(k) number is K152890.

When did SACCADOMETER PLUS, SACCADOMETER ADVANCED receive FDA 510(k) clearance?

SACCADOMETER PLUS, SACCADOMETER ADVANCED received FDA 510(k) clearance on 2016-08-11, under 510(k) number K152890.

Who is the listed applicant for SACCADOMETER PLUS, SACCADOMETER ADVANCED?

The FDA 510(k) record lists Ober Consulting Sp. Z.O.O. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SACCADOMETER PLUS, SACCADOMETER ADVANCED?

The FDA product code for SACCADOMETER PLUS, SACCADOMETER ADVANCED is HLL.

공식 출처

FDA 데이터베이스에서 보기 →

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

SACCADOMETER PLUS, SACCADOMETER ADVANCED

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: HLL)

공식 출처