PEC · Sterilizer Automated Loading System
General Hospital · 21 CFR 880.6880 · Class 2
Overview
| Product Code | PEC |
|---|---|
| Device Name | Sterilizer Automated Loading System |
| Regulation | 21 CFR 880.6880 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K120532 | GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM | Getinge Sourcing, LLC | May 2, 2013 | SESE |
Top Applicants
- Getinge Sourcing, LLC — 1 clearance
