Respiratory Module
Respiratory Module is a Class II device made by Vision RT Limited, cleared under FDA 510(k) K233622 on 29 Mar 2024 and listed in FDA GUDID since 14 Jun 2024 (UDI-DI 05056190500733), active (FDA 510(k)), not in commercial distribution (GUDID) 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 | Number05056190500733 | Date14 Jun 2024 | StatusListed |
| United States | FDA 510(k) | NumberK233622 | Date29 Mar 2024 | StatusActive |
Official records
- AccessGUDID record 05056190500733
- FDA 510(k) database K233622
Across registries
- FDA 510(k) K233622 decided 29 Mar 2024 Active
- FDA GUDID UDI-DI 05056190500733 listed 14 Jun 2024 Listed
Timeline
- Cleared FDA 510(k) K233622
- Listed FDA GUDID 05056190500733
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Radiological video camera patient positioning/tracking system
- Model / Ref / Catalog
- Respiratory Module
- Primary DI / UDI-DI
- 05056190500733
- 510(k) Number
- FDA product code
- IYE
- GMDN term
- Radiological video camera patient positioning/tracking system
- Device class
- Class II
- Regulation number
- 892.5050
- GUDID distribution status
- Not in Commercial Distribution
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