FDA 510(k)

EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand

K-번호: K190715 · 2019-12-13

결정일2019-12-13

제품 코드ERL

자문 위원회EN

결정Substantially Equivalent

기기 요약

EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand is the device name listed in this FDA 510(k) record. The listed applicant is Interscope, Inc.. It received FDA 510(k) clearance on 2019-12-13 under 510(k) number K190715. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand?

EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand is a medical device that received FDA 510(k) clearance on 2019-12-13. The listed applicant is Interscope, Inc.. The 510(k) number is K190715.

When did EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand receive FDA 510(k) clearance?

EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand received FDA 510(k) clearance on 2019-12-13, under 510(k) number K190715.

Who is the listed applicant for EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand?

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

What is the FDA product code for EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand?

The FDA product code for EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand is ERL.

Interscope, Inc.를 신청인으로 등재한 기타 기록

K181127EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control K170120EndoRotor

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