The following data is part of a premarket notification filed by Mie Gmbh with the FDA for Modification To Scintron Iv.
| Device ID | K101013 |
| 510k Number | K101013 |
| Device Name: | MODIFICATION TO SCINTRON IV |
| Classification | System, Tomography, Computed, Emission |
| Applicant | MIE GMBH 420 BENNETT ROAD Elk Grove Village, IL 60007 |
| Contact | Norman Von Hollen |
| Correspondent | Norman Von Hollen MIE GMBH 420 BENNETT ROAD Elk Grove Village, IL 60007 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-12 |
| Decision Date | 2010-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260484140050 | K101013 | 000 |