The following data is part of a premarket notification filed by Nova Medical, Inc. with the FDA for 3t 32 Channel Head Coil.
| Device ID | K182737 |
| 510k Number | K182737 |
| Device Name: | 3T 32 Channel Head Coil |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | Nova Medical, Inc. 150 West Street, Suite 201 Wilmington, MA 01887 |
| Contact | Cheryl Ledden |
| Correspondent | Julie Powell Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-28 |
| Decision Date | 2019-04-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00866613000321 | K182737 | 000 |
| 00866613000307 | K182737 | 000 |