Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer— 510(k) K163337
Substantially EquivalentMidmark Corporation
FDA 510(k) clearance K163337 for Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer, Substantially Equivalent on 2017-08-31. Applicant: Midmark Corporation. Device class: 2.
Clearance details
- Applicant
- Midmark Corporation
- Product code
- Code FLE
- Device class
- Class 2
- Regulation
- 21 CFR 880.6880
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Versailles, OH, US
Recent devices under product code FLE
view allMore clearances from Midmark Corporation
view allAdverse events under product code FLE
product code FLE- Malfunction
- 444
- Total
- 444
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.