510(k) K230531
- Device
- SOZO Pro
- Applicant
- ImpediMed Limited
- 510(k) number
- K230531
- Product code
- QJB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-05-04
- Date received
- 2023-02-27
- Regulation
- 870.2770
- Classification name
- Adjunct Monitor, Protein Calorie Malnutrition
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Dennis Schlaht
- Address
- Unit 1, 50 Parker Ct. Pinkenba AU 4008 4008
FDA Registration Numbers#
- 3004782476
- 3003695829
- 3005699942
Source Documents#
Other 510(k) Records For Product Code QJB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K190529 | SOZO | ImpediMed Limited | 2019-11-25 |