PHILIPS THORAVISION— 510(k) K981657
Substantially EquivalentPhilips Medical Systems North America, Inc.
FDA 510(k) clearance K981657 for PHILIPS THORAVISION, Substantially Equivalent on 1998-06-18. Applicant: Philips Medical Systems North America, Inc.. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems North America, Inc.
- Product code
- Code KPR
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shelton, CT, US
Recent devices under product code KPR
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- K062283 — THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MONITORS
- K061052 — THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90
- K050151 — MULTIDIAGNOST ELEVA
Adverse events under product code KPR
product code KPR- Other
- 6
- Total
- 6
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.