tremoflo C-100 Airwave Oscillometry System & Accesories - US Edition

FDA UDI

Class II (US FDA UDI)

by Thorasys Thoracic Medical Systems Inc

Identity

Trade Name: tremoflo C-100 Airwave Oscillometry System & Accesories - US Edition FDA UDI
Generic Name: Pulmonary function analysis system, adult FDA UDI
Device Name: Airwave Oscillometry System (US version) compatible with ClearFlo PFT filter including power supply, ethernet cable, user manual, and packaged with accessories: tremoFlo unit (DI 07540261013362), test load (DI 07540261009860), CD containing US Software and digital User Manual (DI 07540261016400). System used to measure respiratory system impedance using the Forced Oscillation Technique (FOT). FDA UDI
Model / Reference: 101524 FDA UDI
Description: Airwave Oscillometry System (US version) compatible with ClearFlo PFT filter including power supply, ethernet cable, user manual, and packaged with accessories: tremoFlo unit (DI 07540261013362), test load (DI 07540261009860), CD containing US Software and digital User Manual (DI 07540261016400). System used to measure respiratory system impedance using the Forced Oscillation Technique (FOT). FDA UDI

Identifiers

Primary DI / UDI-DI: 07540261015243 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

tremoflo C-100 Airwave Oscillometry System & Accesories - US Edition by Thorasys Thoracic Medical Systems Inc — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Pulmonary function analysis system, adult.

Volume Calibration Syringe — HANS RUDOLPH, INC. · Class I
VISCOFLU — PHARMA LINE Srl · Class IIb
Volume Calibration Syringe — HANS RUDOLPH, INC. · Class I
CUSTOM PACK FOR NON-INVASIVE VENTILATION — Intersurgical SpA · Class IIa
Vyaire — Jaeger Medical GmbH · Class II
AEROCHAMBER PLUS FLOW-VU — TRUDELL MEDICAL INTERNATIONAL · Class I
Shape II System Refurbished — Shape Medical Systems, Inc. · Class II
CUSTOM PACK FOR NON-INVASIVE VENTILATION — Intersurgical SpA · Class IIa

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Thorasys Thoracic Medical Systems Inc

Sources (1)

FDA UDI c84098c8-a762-4a42-9246-7f24b4b91476 36 fields · synced May 31, 2026