Assembly of tremoflo US software and digital user manual CD

FDA UDI

Class II (US FDA UDI)

by Thorasys Thoracic Medical Systems Inc

Identity

Trade Name: Assembly of tremoflo US software and digital user manual CD FDA UDI
Generic Name: Pulmonary function analysis system, adult FDA UDI
Device Name: CD with US version of tremoflo Oscillometry System Software (DI 07540261013454) and User Manual. FDA UDI
Model / Reference: 101640 FDA UDI
Description: CD with US version of tremoflo Oscillometry System Software (DI 07540261013454) and User Manual. FDA UDI

Identifiers

Primary DI / UDI-DI: 07540261016400 FDA UDI
510(k) Number: K170185 FDA UDI
FDA Product Code: PNV FDA UDI
GMDN Term: Pulmonary function analysis system, adult FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.1840 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Pulmonary function analysis system, adult

Assembly of tremoflo US software and digital user manual CD by Thorasys Thoracic Medical Systems Inc — Class II — FDA UDI — listed in FDA GUDID

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Cleared under the same submission

K170185 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Thorasys Thoracic Medical Systems Inc

Sources (1)

FDA UDI 194d6474-5ea9-4533-b608-f3dfb6ba7523 35 fields · synced May 30, 2026