STERI-VAC GAS STERILIZER MODEL 8XL— 510(k) K941748
Substantially Equivalent3M Health Care, Ltd.
FDA 510(k) clearance K941748 for STERI-VAC GAS STERILIZER MODEL 8XL, Substantially Equivalent on 1994-12-02. Applicant: 3M Health Care, Ltd.. Device class: 2.
Clearance details
- Applicant
- 3M Health Care, Ltd.
- Product code
- Code FLF
- Device class
- Class 2
- Regulation
- 21 CFR 880.6860
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Paul, MN, US
Recent devices under product code FLF
view allMore clearances from 3M Health Care, Ltd.
view allRecalls naming K941748
K-number listed on FDA's recall record- Z-1563-2016 — 3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.
- Z-1318-2014 — 3M" Steri-Vac" Gas Sterilizer/Aerators, Model #'s 4XL,5XL, 8XL The 3M" Steri-Vac" Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for INDOOR USE ONLY.
- Z-0022-2013 — 3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL. 3M Steri-Vac Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for indoor use only.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K941748.
Data sourced from openFDA. This site is unofficial and independent of the FDA.