The following data is part of a premarket notification filed by Medtec, Inc. with the FDA for Head And Neck Immobilization System, Body Immobilization System.
| Device ID | K111340 |
| 510k Number | K111340 |
| Device Name: | HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | MEDTEC, INC. 1401 8TH STREET SE Orange City, IA 51041 |
| Contact | Jenny Jones |
| Correspondent | Jenny Jones MEDTEC, INC. 1401 8TH STREET SE Orange City, IA 51041 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-12 |
| Decision Date | 2011-06-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841439107546 | K111340 | 000 |
| 00841439107485 | K111340 | 000 |
| 00841439107423 | K111340 | 000 |
| 00841439107362 | K111340 | 000 |
| 00841439107294 | K111340 | 000 |
| 00841439102329 | K111340 | 000 |
| 00841439102305 | K111340 | 000 |
| 00841439102299 | K111340 | 000 |
| 00841439102275 | K111340 | 000 |
| 00841439102022 | K111340 | 000 |
| 00841439102343 | K111340 | 000 |
| 00841439107492 | K111340 | 000 |
| 00841439107539 | K111340 | 000 |
| 00841439107478 | K111340 | 000 |
| 00841439107461 | K111340 | 000 |
| 00841439107454 | K111340 | 000 |
| 00841439107447 | K111340 | 000 |
| 00841439107416 | K111340 | 000 |
| 00841439107348 | K111340 | 000 |
| 00841439107287 | K111340 | 000 |
| 00841439107270 | K111340 | 000 |
| 00841439107256 | K111340 | 000 |
| 00841439107591 | K111340 | 000 |
| 00841439102336 | K111340 | 000 |