FDA 510(k)

Aquarius 8600 デジタルレントゲンセンサー

K番号: K181565 · 2018-07-13

決定日2018-07-13

製品コードMQB

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

Aquarius 8600 Digital Radiography Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Biokinemetrics, Inc.. It received FDA 510(k) clearance on 2018-07-13 under 510(k) number K181565. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Aquarius 8600 Digital Radiography Sensor?

Aquarius 8600 Digital Radiography Sensor is a medical device that received FDA 510(k) clearance on 2018-07-13. The listed applicant is Biokinemetrics, Inc.. The 510(k) number is K181565.

When did Aquarius 8600 Digital Radiography Sensor receive FDA 510(k) clearance?

Aquarius 8600 Digital Radiography Sensor received FDA 510(k) clearance on 2018-07-13, under 510(k) number K181565.

Who is the listed applicant for Aquarius 8600 Digital Radiography Sensor?

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

What is the FDA product code for Aquarius 8600 Digital Radiography Sensor?

The FDA product code for Aquarius 8600 Digital Radiography Sensor is MQB.

申請者としてBiokinemetrics, Inc.を記載するその他の記録

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