The following data is part of a premarket notification filed by Tom Medical Entwicklungs Gmbh with the FDA for Medilogar4, Medilogar12.
| Device ID | K070818 |
| 510k Number | K070818 |
| Device Name: | MEDILOGAR4, MEDILOGAR12 |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | TOM MEDICAL ENTWICKLUNGS GMBH ANZENGRUBERGASSE 8 Graz, AT A-8010 |
| Contact | Thomas Hasiba |
| Correspondent | Stefan Preiss TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-03-26 |
| Decision Date | 2007-04-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613365003765 | K070818 | 000 |
| 07613365001952 | K070818 | 000 |
| 07613365001945 | K070818 | 000 |