FDA 510(k)

AIROS 8P Sequential Compression Device

K番号: K223193 · 2022-12-09

決定日2022-12-09

製品コードJOW

諮問委員会以下は、提供された医療機器規制テキストの日本語訳です。 --- **政策：medical-regulatory-v1** --- [ここに原文が記載されています] --- **会社名/製品名**：[ここに会社名または製品名が記載されています] **FDA**：食品医薬品局 **510(k)**：510(k)届出 **PMA**：プレマーケティング評価届出 **NCT**：臨床試験登録番号 **PMID**：PubMed ID **識別子**：[ここに識別子が記載されています] **URL**：[ここにURLが記載されています]

決定大幅同等

医療機器の概要

AIROS 8P Sequential Compression Device is the device name listed in this FDA 510(k) record. The listed applicant is Airos Medical, Inc.. It received FDA 510(k) clearance on 2022-12-09 under 510(k) number K223193. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the AIROS 8P Sequential Compression Device?

AIROS 8P Sequential Compression Device is a medical device that received FDA 510(k) clearance on 2022-12-09. The listed applicant is Airos Medical, Inc.. The 510(k) number is K223193.

When did AIROS 8P Sequential Compression Device receive FDA 510(k) clearance?

AIROS 8P Sequential Compression Device received FDA 510(k) clearance on 2022-12-09, under 510(k) number K223193.

Who is the listed applicant for AIROS 8P Sequential Compression Device?

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

What is the FDA product code for AIROS 8P Sequential Compression Device?

The FDA product code for AIROS 8P Sequential Compression Device is JOW.

申請者としてAiros Medical, Inc.を記載するその他の記録

K240499ARTAIRA Arterial Compression Device (AACD01)K223195AIROS 6P Sequential Compression Device K193069AIROS 6 Sequential Compression Device K193068AIROS 8 Sequential Compression Device K172779AIROS 8 Sequential Compression Device K172770AIROS 6 Sequential Compression Device

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公式ソース

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