M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00
FDA 510(k) clearance K081983 · decided 2008-08-22
Clearance details
- K-number
- K081983
- Device name
- M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00
- Applicant
- Philips Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2008-07-11
- Decision date
- 2008-08-22
- Days to decision
- 42 days
- Clearance type
- Special
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Philips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX recall (Z-0495-2013) | Philips Healthcare Inc. | 2012-12-10 |
| Philips Audio-Video Engineering PAS-210 Remote Active Speakers Kit used with the IntelliVu recall (Z-2217-2011) | Philips Healthcare Inc. | 2011-05-19 |
| Physiological Monitoring, Patient Monitor M31250 Information Center Local Database Release recall (Z-0987-2011) | Philips Healthcare Inc. | 2011-01-27 |
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|---|---|---|
| HeartStart FRx Defibrillator and HeartStart SMART Pads II (P180028/S017) | Philips Medical Systems | 2025-09-05 |
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| HeartStart FRx Defibrillator (P180028/S013) | Philips Medical Systems | 2023-04-03 |
| HeartStart FRx Defibrillator (P180028/S012) | Philips Medical Systems | 2022-03-20 |
| HeartStart FRx Defibrillator (861304) (P180028/S011) | Philips Medical Systems | 2021-11-15 |
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