PEC — Sterilizer Automated Loading System Class II
FDA product code PEC covers "Sterilizer Automated Loading System", a Class II medical device regulated under 21 CFR 880.6880. Submissions are reviewed by the General Hospital panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PEC
- Device Class
- Class II
- Regulation Number
- 880.6880
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Definition
Provides automated loading and unloading of instruments requiring sterilization for increasing hospital work flow efficiencies. The system consists of a user interface, loading conveyor, load transport shuttles, unloading conveyor to be used as an accessory to a sterilizer.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K120532 | getinge sourcing | GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM | May 2, 2013 |