PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521— 510(k) K071391
Substantially EquivalentPhilips Medical Systems, Inc.
FDA 510(k) clearance K071391 for PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521, Substantially Equivalent on 2007-09-07. Applicant: Philips Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems, Inc.
- 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.