Volu-Sol Orange G-6(Gills-Mod
by Volu Sol Medical Industries 510(k)
Active
510(k) K822038
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK822038 | Date3 Aug 1982 | 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- Withdrawn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
- HZH
- Device Class
- Class I
- Regulation
- 21 CFR Part 864.1850
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent