Ebw NM 2.0
FDA 510(k) K111336 · Philips Medical Systems (Cleveland), Inc.
510(k) numberK111336
Submission
- Device name
- Ebw NM 2.0
- Applicant
- Philips Medical Systems (Cleveland), Inc.
San Jose, CA, US - Received
- May 12, 2011
- Decision date
- May 24, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was Ebw NM 2.0 cleared by the FDA?
Ebw NM 2.0 (K111336) received a 510(k) decision of Substantially Equivalent on May 24, 2011, 12 days after the submission was received.
What is the product code of K111336?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.