The following data is part of a premarket notification filed by Invivo Corp. with the FDA for Neurovascular Array Coil, Model Nva-127-16-a.
| Device ID | K052497 |
| 510k Number | K052497 |
| Device Name: | NEUROVASCULAR ARRAY COIL, MODEL NVA-127-16-A |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | INVIVO CORP. N27 W23676 PAUL ROAD Pewaukee, WI 53072 |
| Contact | Tom Schubert |
| Correspondent | Tom Schubert INVIVO CORP. N27 W23676 PAUL ROAD Pewaukee, WI 53072 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-12 |
| Decision Date | 2005-10-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838067172 | K052497 | 000 |