The following data is part of a premarket notification filed by Irt Systems with the FDA for Iqm Integral Quality Monitor (also Iqm).
| Device ID | K162629 |
| 510k Number | K162629 |
| Device Name: | IQM Integral Quality Monitor (also IQM) |
| Classification | Accelerator, Linear, Medical |
| Applicant | IRT SYSTEMS SCHLOSSTRASSE 1 Koblenz, DE 56068 |
| Contact | Juergen Oellig |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2016-09-21 |
| Decision Date | 2016-10-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B50510130 | K162629 | 000 |