The following data is part of a premarket notification filed by Invivo Corporation (business Trade Name: Philips) with the FDA for Ds Head 32ch 3.0t.
| Device ID | K213351 |
| 510k Number | K213351 |
| Device Name: | Ds Head 32ch 3.0T |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | Invivo Corporation (Business Trade Name: Philips) 3545 SW 47th Ave Gainesville, FL 32608 |
| Contact | Sarah Pleaugh |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | MOS |
| Subsequent Product Code | LNH |
| Subsequent Product Code | LNI |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-10-08 |
| Decision Date | 2021-10-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838098602 | K213351 | 000 |
| 00884838118119 | K213351 | 000 |