The following data is part of a premarket notification filed by Medical Graphics Corp. with the FDA for Resmon Pro Full.
| Device ID | K152585 |
| 510k Number | K152585 |
| Device Name: | Resmon PRO FULL |
| Classification | Impedance Measuring Device Utilizing Oscillation Techniques |
| Applicant | MEDICAL GRAPHICS CORP. 350 OAK GROVE PARKWAY St. Paul, MN 55127 |
| Contact | Jim Purdie |
| Correspondent | Paul Dryden MEDICAL GRAPHICS CORP. 350 OAK GROVE PARKWAY St. Paul, MN 55127 |
| Product Code | PNV |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-10 |
| Decision Date | 2016-06-24 |
| Summary: | summary |