STATIM 6000B Vacuum Autoclave
by Scican Ltd
510(k) K214057
STATIM 6000B Vacuum Autoclave is a Class II device made by Scican Ltd, cleared under FDA 510(k) K214057 on 31 Mar 2022, 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 | FDA 510(k)SESE | NumberK214057 | Date31 Mar 2022 | StatusActive |
Official records
- FDA 510(k) database K214057
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FLE
- FDA applicant
- Scican , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 880.6880
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
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