Models: 52-01-0, 52-01-1
by Y 510(k)
Active
510(k) K811110
Overview
The device is a product identified by models 52-01-0 and 52-01-1, manufactured by Y. It is classified under product code FPA and was determined to be substantially equivalent.
The device is supplied for use in general hospital settings and is authorized under FDA 510K clearance with K number K811110. It is not a third-party device and was reviewed by the HO advisory committee.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK811110 | Date11 Jun 1981 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FPA
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5440
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from Y
Questions
What are the models of this device and who manufactures it?
The device is available in models 52-01-0 and 52-01-1, manufactured by Y. These models are designed for use in general hospital settings.
What is the regulatory status of this device?
The device is authorized under FDA 510K clearance with K number K811110 and was determined to be substantially equivalent. It was reviewed by the HO advisory committee.
In what settings is this device intended to be used?
The device is supplied for use in general hospital settings. It is classified under product code FPA and is not a third-party device.
When was this device cleared by the FDA?
The device received FDA clearance on June 11, 1981, with the application received on April 23, 1981. It was determined to be substantially equivalent under the traditional clearance type.