Professional Suite 0000PS100
by Dorsavi Ltd
Professional Suite 0000PS100 is a Class I device made by Dorsavi Ltd, cleared under FDA 510(k) K163150 on 14 Jul 2017 and listed in FDA GUDID since 26 Sep 2019 (UDI-DI B7580000PS100), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB7580000PS100 | Date26 Sep 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK163150 | Date14 Jul 2017 | StatusActive |
Official records
- FDA 510(k) database K163150
Across registries
- FDA 510(k) K163150 decided 14 Jul 2017 Active
- FDA GUDID UDI-DI B7580000PS100 listed 26 Sep 2019 Listed
Timeline
- Cleared FDA 510(k) K163150
- Listed FDA GUDID B7580000PS100
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Professional Suite
- Generic name
- Psychophysiological biofeedback system
- Model / Ref / Catalog
- 0000PS100, PS100
- Primary DI / UDI-DI
- B7580000PS100
- 510(k) Number
- FDA product code
- KQX, HCC, IKN
- GMDN term
- Psychophysiological biofeedback system
- Device class
- Class I
- Regulation number
- 888.1500, 882.5050, 890.1375
- GUDID distribution status
- In Commercial Distribution
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