PATIENT CONTROLLED SYRINGE PUMP TYPE 3300— 510(k) K915270
Substantially EquivalentGraseby Medical , Ltd.
FDA 510(k) clearance K915270 for PATIENT CONTROLLED SYRINGE PUMP TYPE 3300, Substantially Equivalent on 1992-08-24. Applicant: Graseby Medical , Ltd.. Device class: 2.
Clearance details
- Applicant
- Graseby Medical , Ltd.
- Product code
- Code MEA
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Watford, Herts., GB
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More clearances from Graseby Medical , Ltd.
view allAdverse events under product code MEA
product code MEA- Death
- 19
- Malfunction
- 25,089
- Total
- 25,108
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 K915270
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 K915270.
Data sourced from openFDA. This site is unofficial and independent of the FDA.