STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM— 510(k) K032303
Substantially EquivalentStryker Instruments
FDA 510(k) clearance K032303 for STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM, Substantially Equivalent on 2004-01-16. Applicant: Stryker Instruments. Device class: 2.
Clearance details
- Applicant
- Stryker Instruments
- Product code
- Product code HBE
- Device class
- Class 2
- Regulation
- 21 CFR 882.4310
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kalamazoo, MI, US
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Adverse events under product code HBE
product code HBE- Injury
- 306
- Malfunction
- 7,175
- Other
- 1
- Total
- 7,482
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.