OWEN MUMFORD 3ML AUTOPEN— 510(k) K983974
Substantially EquivalentOwen Mumford USA, Inc.
FDA 510(k) clearance K983974 for OWEN MUMFORD 3ML AUTOPEN, Substantially Equivalent on 1998-12-21. Applicant: Owen Mumford USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Owen Mumford USA, Inc.
- Product code
- Code FMF
- Device class
- Class 2
- Regulation
- 21 CFR 880.5860
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marietta, GA, US
Recent devices under product code FMF
view allMore clearances from Owen Mumford USA, Inc.
view allAdverse events under product code FMF
product code FMF- Death
- 15
- Injury
- 2,263
- Malfunction
- 29,722
- Other
- 17
- Total
- 32,017
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 →
Recalls naming K983974
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K983974.
Data sourced from openFDA. This site is unofficial and independent of the FDA.