The following data is part of a premarket notification filed by Neurophet, Inc. with the FDA for Neurophet Scale Pet.
| Device ID | K221405 |
| 510k Number | K221405 |
| Device Name: | Neurophet SCALE PET |
| Classification | System, Image Processing, Radiological |
| Applicant | NEUROPHET, Inc. 12F, 124, Teheran-ro, Gangnam-gu Seoul, KR |
| Contact | Boreum Yoo |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc 18881 Von Karman Ave. STE 160 Irvine, CA 92612 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-16 |
| Decision Date | 2022-08-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800130400174 | K221405 | 000 |