Universal Digital Interface Wireless - Udi 1417W
FDA 510(k) K111305 · Meridian Medical Systems, LLC
510(k) numberK111305
Submission
- Device name
- Universal Digital Interface Wireless - Udi 1417W
- Applicant
- Meridian Medical Systems, LLC
Aurora, OH, US - Received
- May 9, 2011
- Decision date
- January 31, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K140251 | Universal Digital Interface 2, Udi 2MQB · Traditional | 10/22/2014SE |
| K112527 | Universal Digital Interface (Udi) 1717MQB · Traditional | 05/22/2012SE |
| K103599 | Universal Digital Interface (Udi) 1717MQB · Traditional | 04/27/2011SE |
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| K944157 | Disposable, Preformed Face MaskBSJ · Traditional | 10/03/1994SE |
Questions and answers
When was Universal Digital Interface Wireless - Udi 1417W cleared by the FDA?
Universal Digital Interface Wireless - Udi 1417W (K111305) received a 510(k) decision of Substantially Equivalent on January 31, 2012, 267 days after the submission was received.
What is the product code of K111305?
The FDA product code is MQB – Solid State X-Ray Imager (Flat Panel/Digital Imager), a Class II (moderate risk) device regulated under 21 CFR 892.1680.