BORA UP 2080, BORA UP 2080 OP AND BORA UP 2080 MOUNTING— 510(k) K092903
Substantially EquivalentMaquet GmbH and Co. KG
FDA 510(k) clearance K092903 for BORA UP 2080, BORA UP 2080 OP AND BORA UP 2080 MOUNTING, Substantially Equivalent on 2009-12-01. Applicant: Maquet GmbH and Co. KG. Device class: 2.
Clearance details
- Applicant
- Maquet GmbH and Co. KG
- Product code
- Product code BTA
- Device class
- Class 2
- Regulation
- 21 CFR 878.4780
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rastatt De-Bw, DE
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Adverse events under product code BTA
product code BTA- Death
- 5
- Total
- 5
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.