PHILIPS TELEMEDICINE SERVER/SYSTEM, MODEL 861441— 510(k) K091176
Substantially EquivalentPhilips Medical Systems
FDA 510(k) clearance K091176 for PHILIPS TELEMEDICINE SERVER/SYSTEM, MODEL 861441, Substantially Equivalent on 2009-11-13. Applicant: Philips Medical Systems. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems
- Product code
- Code MSX
- Device class
- Class 2
- Regulation
- 21 CFR 870.2300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Andover, MA, US
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Adverse events under product code MSX
product code MSX- Death
- 59
- Total
- 59
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.