PEC
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Sterilizer Automated Loading System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6880
- Medical specialty
- General Hospital
- Flags
- Third-party review eligible
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM (K120532) | Getinge Sourcing, LLC | 2013-05-02 |
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