The following data is part of a premarket notification filed by Novasignal Corporation with the FDA for Novaguide 2 Intelligent Ultrasound.
| Device ID | K213279 |
| 510k Number | K213279 |
| Device Name: | NovaGuide 2 Intelligent Ultrasound |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | NovaSignal Corporation 2440 S. Sepulveda Blvd., Ste 115 Los Angeles, CA 90064 |
| Contact | Raajdeep (raaj) Venkatesan |
| Correspondent | Carrene Plummer NovaSignal Corporation 2440 S. Sepulveda Blvd., Ste 115 Los Angeles, CA 90064 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | OQQ |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-01 |
| Decision Date | 2022-03-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850681007405 | K213279 | 000 |
| 00850681007399 | K213279 | 000 |
| 00850681007351 | K213279 | 000 |