MPR-814
FDA 510(k) K940442 · Xri, Inc.
510(k) numberK940442
Submission
- Device name
- MPR-814
- Applicant
- Xri, Inc.
Tustin, CA, US - Received
- February 1, 1994
- Decision date
- June 9, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code IYB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K935123 | Superstand 300IYB · Traditional | Wuestec Medical, Inc. | 03/27/1996SE |
| K946261 | MTS-007, STS-008, SSMTS-010, EURO-40, 72, Super Euro 4072, 5000IYB · Traditional | Scott Imaging Intl., Inc. | 02/15/1995SE |
| K941017 | F/C/W TubestandIYB · Traditional | Acoma Medical Imaging, Inc. | 07/29/1994SE |
| K941004 | CTS SystemIYB · Traditional | Acoma Medical Imaging, Inc. | 07/29/1994SE |
| K935004 | Model Alpha TS-2IYB · Traditional | Dpa Consulting, Inc. | 12/13/1993SE |
| K933253 | Superstand 3000IYB · Traditional | Wuestec Medical, Inc. | 08/16/1993SE |
| K925716 | Bennett Overhead Tube Crane Model No. B-OtcIYB · Traditional | Bennett X-Ray Corp. | 12/17/1992SE |
| K925170 | Shimadzu X-Ray Tube Stand BH-100 SeriesIYB · Traditional | Shimadzu Medical Systems | 12/07/1992SE |
| K920727 | Ceiling Tube Support CH-30XIYB · Traditional | Shimadzu Medical Systems | 04/16/1992SE |
| K914944 | Bennett Overhead Tube Crane Model No. B-OtcIYB · Traditional | Bennett X-Ray Corp. | 12/02/1991SE |
Questions and answers
When was MPR-814 cleared by the FDA?
MPR-814 (K940442) received a 510(k) decision of Substantially Equivalent on June 9, 1994, 128 days after the submission was received.
What is the product code of K940442?
The FDA product code is IYB – Tube Mount, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1770.