FDA Registration
Active
🇦🇺 Australia
wheezo
Reg #: 3021974922
·
FEI: 3021974922
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- RESPIRI LIMITED
- Registration Number
- 3021974922
- FEI Number
- 3021974922
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Suite 1, Level 9, 432 St Kilda Road
- City
- Melbourne Victoria
- Country
- AU
Regulatory Submissions
- 510(k) Number
- K202062
Owner / Operator
- Firm Name
- Respiri Limited
- Operator Number
- 10084368
- Address
- Suite 1, Level 9, 432 St Kilda Road
- City
- Melbourne
- State
- Victoria
- Postal Code
- 3004
- Country
- AU
- Correspondent
- Peter Hildebrandt
US Agent
- Business Name
- Respiri USA, Inc.
- Contact Name
- Mat Robie
- Address
- 360 N Pacific Coast Hwy Ste 2000
- City
- El Segundo
- State
- CA
- ZIP
- 90245
- Country
- US
- [email protected]
- Phone
- 520 3314255
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Abnormal Breath Sound Device | PHZ | Class 2 | Anesthesiology | No | 2022-02-14 |
Proprietary Names
wheezo
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility