FDA 510(k)

AMSure Sterile Water, and Sterile Normal Saline for Wound Flush

Número K: K181423 · 2018-09-07

Data da decisão2018-09-07

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

AMSure Sterile Water, and Sterile Normal Saline for Wound Flush is the device name listed in this FDA 510(k) record. The listed applicant is Amsino International, Inc.. It received FDA 510(k) clearance on 2018-09-07 under 510(k) number K181423. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AMSure Sterile Water, and Sterile Normal Saline for Wound Flush?

AMSure Sterile Water, and Sterile Normal Saline for Wound Flush is a medical device that received FDA 510(k) clearance on 2018-09-07. The listed applicant is Amsino International, Inc.. The 510(k) number is K181423.

When did AMSure Sterile Water, and Sterile Normal Saline for Wound Flush receive FDA 510(k) clearance?

AMSure Sterile Water, and Sterile Normal Saline for Wound Flush received FDA 510(k) clearance on 2018-09-07, under 510(k) number K181423.

Who is the listed applicant for AMSure Sterile Water, and Sterile Normal Saline for Wound Flush?

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

What is the FDA product code for AMSure Sterile Water, and Sterile Normal Saline for Wound Flush?

The FDA product code for AMSure Sterile Water, and Sterile Normal Saline for Wound Flush is FRO. This falls under the Anesthesiology category.

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Outros registros que listam Amsino International, Inc. como candidato(a)

K252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)K220230AMSure Enteral Feeding Pump K220267AMSafe NeuFlo Needleless Connector K213522AMSafe Pre-Filled Normal Saline Flush Syringe K200051PUGGLE Enteral Feeding Pump and Feeding Set K183473AMSafe(R) Pre-Filled Normal Saline Flush Syringe

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Fonte oficial

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