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AirPhysio

EUDAMEDFDA 510(k)

Class I (EU MDR)

Ref 9369998021505Model AirPhysio Average Lung Device510(k) K203209

by AirPhysio Pty Ltd

Identity

Trade Name
AirPhysio EUDAMED
Device Name
AirPhysio OPEP Device EUDAMED
Model / Reference
AirPhysio Average Lung Device EUDAMED
9369998021505 EUDAMED

Identifiers

Primary DI / UDI-DI
+B99893699990588901/$AN-711220130725+ EUDAMED
Basic UDI-DI
++B99836999802150505J EUDAMED
Direct Marketing DI
9359191093699981504E EUDAMED
510(k) Number
K203209 FDA 510(k)
FDA Product Code
BYI FDA 510(k)
EMDN Code
R900902 INSPIRATORY AND EXPIRATORY FLOW STIMULATORS/RESPIRATORY MUSCLES TRAINERS EUDAMED

Classification

Device Class
Class I EUDAMED
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5665 FDA 510(k)
Regulation Number
868.5665 FDA 510(k)
Market of Registration
Austria EUDAMED
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

Yes

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

AirPhysio by Airphysio Pty. Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
AirPhysio Pty Ltd
EUDAMED SRN
AU-MF-000052052
Authorised Representative
Luft For Life Österreich Ltd AT-AR-000020403

Sources (2)

  • EUDAMED 1e6d8094-b758-4fbf-be7f-dd6ceebf5f55 61 fields · synced Jun 20, 2026
  • FDA 510(k) K203209 24 fields · synced May 18, 2026