Steri-Vac Gas Sterilizer Model 8XL
FDA 510(k) K941748 · 3M Health Care, Ltd.
510(k) numberK941748
Submission
- Device name
- Steri-Vac Gas Sterilizer Model 8XL
- Applicant
- 3M Health Care, Ltd.
St. Paul, MN, US - Received
- April 8, 1994
- Decision date
- December 2, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FLF – Sterilizer, Ethylene-Oxide Gas
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6860
- Specialty
- General Hospital
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Questions and answers
When was Steri-Vac Gas Sterilizer Model 8XL cleared by the FDA?
Steri-Vac Gas Sterilizer Model 8XL (K941748) received a 510(k) decision of Substantially Equivalent on December 2, 1994, 238 days after the submission was received.
What is the product code of K941748?
The FDA product code is FLF – Sterilizer, Ethylene-Oxide Gas, a Class II (moderate risk) device regulated under 21 CFR 880.6860.