KARLSON OZONE STERILIZER MODEL 100B
Device Facts
| Record ID | K873200 |
|---|---|
| Device Name | KARLSON OZONE STERILIZER MODEL 100B |
| Applicant | Life Enhancement Technologies, LLC |
| Product Code | FLF · General Hospital |
| Decision Date | Jan 27, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6860 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products.
