FDA 510(k)

tremoFlo C-100 空气波振荡测量系统

K号: K170185 · 2017-09-12

申请人Thorasys Thoracic Medical Systems, Inc.

决定日期2017-09-12

产品代码PNV

咨询委员会AN 请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。

决定实质等同

器械摘要

tremoFlo C-100 Airwave Oscillometry System is the device name listed in this FDA 510(k) record. The listed applicant is Thorasys Thoracic Medical Systems, Inc.. It received FDA 510(k) clearance on 2017-09-12 under 510(k) number K170185. The device is classified under product code PNV. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the tremoFlo C-100 Airwave Oscillometry System?

tremoFlo C-100 Airwave Oscillometry System is a medical device that received FDA 510(k) clearance on 2017-09-12. The listed applicant is Thorasys Thoracic Medical Systems, Inc.. The 510(k) number is K170185.

When did tremoFlo C-100 Airwave Oscillometry System receive FDA 510(k) clearance?

tremoFlo C-100 Airwave Oscillometry System received FDA 510(k) clearance on 2017-09-12, under 510(k) number K170185.

Who is the listed applicant for tremoFlo C-100 Airwave Oscillometry System?

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

What is the FDA product code for tremoFlo C-100 Airwave Oscillometry System?

The FDA product code for tremoFlo C-100 Airwave Oscillometry System is PNV.

列明Thorasys Thoracic Medical Systems, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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