NFLK-2501 Portable X-ray Unit
FDA 510(k) K211383 · Neuf, Inc.
510(k) numberK211383
Submission
- Device name
- NFLK-2501 Portable X-ray Unit
- Applicant
- Neuf, Inc.
Jeollanam-Do, KR - Received
- May 4, 2021
- Decision date
- August 13, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was NFLK-2501 Portable X-ray Unit cleared by the FDA?
NFLK-2501 Portable X-ray Unit (K211383) received a 510(k) decision of Substantially Equivalent on August 13, 2021, 101 days after the submission was received.
What is the product code of K211383?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.