FDA 510(k)

PRIMED手術マスクおよびPRIMED手順マスク

K番号: K240286 · 2024-08-26

決定日2024-08-26

製品コードFXX

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

PRIMED Surgical Masks and PRIMED Procedure Masks is the device name listed in this FDA 510(k) record. The listed applicant is Primed Medical Products, Inc.. It received FDA 510(k) clearance on 2024-08-26 under 510(k) number K240286. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the PRIMED Surgical Masks and PRIMED Procedure Masks?

PRIMED Surgical Masks and PRIMED Procedure Masks is a medical device that received FDA 510(k) clearance on 2024-08-26. The listed applicant is Primed Medical Products, Inc.. The 510(k) number is K240286.

When did PRIMED Surgical Masks and PRIMED Procedure Masks receive FDA 510(k) clearance?

PRIMED Surgical Masks and PRIMED Procedure Masks received FDA 510(k) clearance on 2024-08-26, under 510(k) number K240286.

Who is the listed applicant for PRIMED Surgical Masks and PRIMED Procedure Masks?

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

What is the FDA product code for PRIMED Surgical Masks and PRIMED Procedure Masks?

The FDA product code for PRIMED Surgical Masks and PRIMED Procedure Masks is FXX.

申請者としてPrimed Medical Products, Inc.を記載するその他の記録

K262007PRIMED AAMIレベル3オープンバックのガウン K261811PRIMED 化学療法薬試験グウン（PM4-99450：PRIMED 化学療法薬試験隔離グウン、紫、AAMIレベル2；PM4-99460：PRIMED 化学療法薬試験隔離グウン、青、AAMIレベル3）K252964PRIMED手術および手術マスク K242208PRIMED 殺菌包装（P100、P200、P300、P400、P500、P600）K233777PRIMED 殺菌包装（P100、P200、P300、P400、P500、P600）K213427PRIMED 小児用フェースマスク

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