FDA 510(k)

フィリップスエイブントコンフォートシングル/ツインエレクトリックビストルプンプ

K番号: K161532 · 2016-08-29

申請者Philips Consumer Lifestyle - Innovation Site Eindhoven

決定日2016-08-29

製品コードHGX

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OB [翻訳] OB

決定大幅同等

医療機器の概要

Philips Avent Comfort Single/Twin Electric Breast Pump is the device name listed in this FDA 510(k) record. The listed applicant is Philips Consumer Lifestyle - Innovation Site Eindhoven. It received FDA 510(k) clearance on 2016-08-29 under 510(k) number K161532. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Philips Avent Comfort Single/Twin Electric Breast Pump?

Philips Avent Comfort Single/Twin Electric Breast Pump is a medical device that received FDA 510(k) clearance on 2016-08-29. The listed applicant is Philips Consumer Lifestyle - Innovation Site Eindhoven. The 510(k) number is K161532.

When did Philips Avent Comfort Single/Twin Electric Breast Pump receive FDA 510(k) clearance?

Philips Avent Comfort Single/Twin Electric Breast Pump received FDA 510(k) clearance on 2016-08-29, under 510(k) number K161532.

Who is the listed applicant for Philips Avent Comfort Single/Twin Electric Breast Pump?

The FDA 510(k) record lists Philips Consumer Lifestyle - Innovation Site Eindhoven as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Philips Avent Comfort Single/Twin Electric Breast Pump?

The FDA product code for Philips Avent Comfort Single/Twin Electric Breast Pump is HGX.

申請者としてPhilips Consumer Lifestyle - Innovation Site Eindhovenを記載するその他の記録

K203383フィリップス・アベントダブル電動搾乳器 Advanced SCF394/61、フィリップス・アベントダブル電動搾乳器 Advanced SCF394/62 K201381Philips Avent シングル/ダブル電動搾乳器アドバンス

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