FDA 510(k)

NeoConnect 口服/経腸注射筒（12 mLから100 mL）および NeoConnect 低用量先端口服/経腸注射筒（0.5 mLから6 mL）をENFitコネクタ搭載

K番号: K161039 · 2016-06-17

決定日2016-06-17

製品コードPNR

諮問委員会以下は、指定された医療機器規制テキストの日本語訳です。以下の医療機器規制テキストを日本語に翻訳してください。会社名、製品名、FDA、510(k)、PMA、NCT、PMID、識別子、およびURLを保護してください。ポリシー：medical-regulatory-v1 [原文] GU [翻訳] GU

決定大幅同等

医療機器の概要

NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL) is the device name listed in this FDA 510(k) record. The listed applicant is Neomed, Inc.. It received FDA 510(k) clearance on 2016-06-17 under 510(k) number K161039. The device is classified under product code PNR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL)?

NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL) is a medical device that received FDA 510(k) clearance on 2016-06-17. The listed applicant is Neomed, Inc.. The 510(k) number is K161039.

When did NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL) receive FDA 510(k) clearance?

NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL) received FDA 510(k) clearance on 2016-06-17, under 510(k) number K161039.

Who is the listed applicant for NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL)?

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

What is the FDA product code for NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL)?

The FDA product code for NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL) is PNR.

申請者としてNeomed, Inc.を記載するその他の記録

K183540口内/経口注射器（12 mLから60 mL）、低用量先端口内/経口注射器（1 mLから6 mL）ENFitコネクタ付き

公式ソース

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