VHP 136 Low Temperature Sterilization System
FDA 510(k) K062297 · STERIS Corporation
510(k) numberK062297
Submission
- Device name
- VHP 136 Low Temperature Sterilization System
- Applicant
- STERIS Corporation
Mentor, OH, US - Received
- August 7, 2006
- Decision date
- October 4, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MLR – Sterilizer, Chemical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6860
- Specialty
- General Hospital
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Questions and answers
When was VHP 136 Low Temperature Sterilization System cleared by the FDA?
VHP 136 Low Temperature Sterilization System (K062297) received a 510(k) decision of Substantially Equivalent on October 4, 2007, 423 days after the submission was received.
What is the product code of K062297?
The FDA product code is MLR – Sterilizer, Chemical, a Class II (moderate risk) device regulated under 21 CFR 880.6860.