BBS Revolution™ PD-010-0002
by Dbmedx, Inc.
BBS Revolution PD-010-0002 is a bladder volume ultrasound imaging system (FDA Class II) made by Dbmedx, Inc., cleared under FDA 510(k) K142329 on 15 Dec 2014 and listed in FDA GUDID since 11 Mar 2019 (UDI-DI 00869209000200), active as of 22 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 | Number00869209000200 | Date11 Mar 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK142329 | Date15 Dec 2014 | StatusActive |
Official records
- AccessGUDID record 00869209000200
- FDA 510(k) database K142329
Across registries
- FDA 510(k) K142329 decided 15 Dec 2014 Active
- FDA GUDID UDI-DI 00869209000200 listed 11 Mar 2019 Listed
Timeline
- Cleared FDA 510(k) K142329
- Listed FDA GUDID 00869209000200
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- BBS Revolution™
- Generic name
- Bladder volume ultrasound imaging system
- Model / Ref / Catalog
- PD-010-0002
- Primary DI / UDI-DI
- 00869209000200
- 510(k) Number
- FDA product code
- ITX, IYO
- GMDN term
- Bladder volume ultrasound imaging system
- Device class
- Class II
- Regulation number
- 892.1570, 892.1560
- GUDID distribution status
- In Commercial Distribution
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