The following data is part of a premarket notification filed by Medtec, Inc. with the FDA for Mri Patient Positioning Devices.
| Device ID | K093738 |
| 510k Number | K093738 |
| Device Name: | MRI PATIENT POSITIONING DEVICES |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | MEDTEC, INC. 102 FIRST STREET SOUTH Kalona, IA 52247 -9589 |
| Contact | James Leong |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-12-04 |
| Decision Date | 2010-05-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841439104095 | K093738 | 000 |
| 00841439103050 | K093738 | 000 |
| 00841439103043 | K093738 | 000 |
| 00841439103036 | K093738 | 000 |
| 00841439103029 | K093738 | 000 |
| 00841439113080 | K093738 | 000 |
| 00841439113431 | K093738 | 000 |
| 00841439114094 | K093738 | 000 |
| 00841439114087 | K093738 | 000 |
| 00841439114070 | K093738 | 000 |
| 00841439114063 | K093738 | 000 |
| 00841439103067 | K093738 | 000 |
| 00841439103074 | K093738 | 000 |
| 00841439103081 | K093738 | 000 |
| 00841439104088 | K093738 | 000 |
| 00841439104071 | K093738 | 000 |
| 00841439104064 | K093738 | 000 |
| 00841439112595 | K093738 | 000 |
| 00841439110683 | K093738 | 000 |
| 00841439107621 | K093738 | 000 |
| 00841439107614 | K093738 | 000 |
| 00841439107607 | K093738 | 000 |
| 00841439107058 | K093738 | 000 |
| 00841439103098 | K093738 | 000 |
| 00841439114056 | K093738 | 000 |