The following data is part of a premarket notification filed by Sentinelle Medical, Inc. with the FDA for Vanguard Mri Auxiliary Patient Table With 4 And 8 Channel Coil Array For Ge Signa Systems.
| Device ID | K060873 |
| 510k Number | K060873 |
| Device Name: | VANGUARD MRI AUXILIARY PATIENT TABLE WITH 4 AND 8 CHANNEL COIL ARRAY FOR GE SIGNA SYSTEMS |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | SENTINELLE MEDICAL, INC. 3080 YONGE STREET SUITE 6020 Toronto, Ontario, CA M4n 3n1 |
| Contact | Cameron Piron |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-03-30 |
| Decision Date | 2006-04-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838084537 | K060873 | 000 |
| 00884838081536 | K060873 | 000 |
| 00884838081567 | K060873 | 000 |
| 00884838081574 | K060873 | 000 |
| 00884838081697 | K060873 | 000 |
| 00884838081727 | K060873 | 000 |
| 00884838081734 | K060873 | 000 |
| 00884838083608 | K060873 | 000 |
| 00884838083615 | K060873 | 000 |
| 00884838080966 | K060873 | 000 |