The following data is part of a premarket notification filed by Nodecrest Llc with the FDA for Nodecrest Transcranical Doppler Ultrasound System.
| Device ID | K060112 |
| 510k Number | K060112 |
| Device Name: | NODECREST TRANSCRANICAL DOPPLER ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | NODECREST LLC 1676 VILLAGE GREEN, SUITE A Corfton, MD 21114 |
| Contact | E. J Smith |
| Correspondent | E. J Smith NODECREST LLC 1676 VILLAGE GREEN, SUITE A Corfton, MD 21114 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-17 |
| Decision Date | 2006-05-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970481940024 | K060112 | 000 |
| 06970481940017 | K060112 | 000 |