AMSCO 600 Steam Sterilizer
Device Facts
| Record ID | K232485 |
|---|---|
| Device Name | AMSCO 600 Steam Sterilizer |
| Applicant | Steris |
| Product Code | FLE · General Hospital |
| Decision Date | Sep 13, 2023 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 880.6880 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.