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FDA 510(k)

tremoflo C2 Airwave Oscillometry System

K-Number: K221024 · 2023-06-20

ApplicantThorasys Thoracic Medical Systems, Inc.
Decision Date2023-06-20
Product CodePNV
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

tremoflo C2 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 2023-06-20 under 510(k) number K221024. The device is classified under product code PNV. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the tremoflo C2 Airwave Oscillometry System?

tremoflo C2 Airwave Oscillometry System is a medical device that received FDA 510(k) clearance on 2023-06-20. The listed applicant is Thorasys Thoracic Medical Systems, Inc.. The 510(k) number is K221024.

When did tremoflo C2 Airwave Oscillometry System receive FDA 510(k) clearance?

tremoflo C2 Airwave Oscillometry System received FDA 510(k) clearance on 2023-06-20, under 510(k) number K221024.

Who is the listed applicant for tremoflo C2 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 C2 Airwave Oscillometry System?

The FDA product code for tremoflo C2 Airwave Oscillometry System is PNV.

Other records listing Thorasys Thoracic Medical Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K170185tremoFlo C-100 Airwave Oscillometry System

Related Devices (Code: PNV)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K191876PulmoScanCognita Labs, LLCK170185tremoFlo C-100 Airwave Oscillometry SystemThorasys Thoracic Medical Systems, Inc.K152585Resmon PRO FULLMedical Graphics Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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