Philips BV Libra
FDA 510(k) K010762 · Philips Medical Systems, Inc.
510(k) numberK010762
Submission
- Device name
- Philips BV Libra
- Applicant
- Philips Medical Systems, Inc.
Da Best, NL - Received
- March 14, 2001
- Decision date
- April 2, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Philips BV Libra cleared by the FDA?
Philips BV Libra (K010762) received a 510(k) decision of Substantially Equivalent on April 2, 2001, 19 days after the submission was received.
What is the product code of K010762?
The FDA product code is OXO – Image-Intensified Fluoroscopic X-Ray System, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1650.