The following data is part of a premarket notification filed by Therataxis, Llc with the FDA for Molecular Flow Simulations.
| Device ID | K201435 |
| 510k Number | K201435 |
| Device Name: | Molecular Flow Simulations |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | Therataxis, LLC Johns Hopkins Eastern Building Suite B305 1101 East 33rd Street Baltimore, MD 21218 |
| Contact | Raghu Raghavan |
| Correspondent | Al Memmolo Convergent Clinical, Inc. 6648 Surf Crest St. Carlsbad, CA 92011 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-01 |
| Decision Date | 2021-12-03 |