COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E— 510(k) K023354
Substantially EquivalentSiemens Elema AB
FDA 510(k) clearance K023354 for COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E, Substantially Equivalent on 2003-09-05. Applicant: Siemens Elema AB. Device class: 2.
Clearance details
- Applicant
- Siemens Elema AB
- Product code
- Code BTI
- Device class
- Class 2
- Regulation
- 21 CFR 868.6250
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Danvers, MA, US
Recent devices under product code BTI
view allMore clearances from Siemens Elema AB
view allAdverse events under product code BTI
product code BTI- Death
- 25
- Malfunction
- 1,168
- Total
- 1,193
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 K023354
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 K023354.
Data sourced from openFDA. This site is unofficial and independent of the FDA.