The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Nka Model Mfv-3100 & Mfv-3200 Electro. Blood Flow..
| Device ID | K894631 |
| 510k Number | K894631 |
| Device Name: | NKA MODEL MFV-3100 & MFV-3200 ELECTRO. BLOOD FLOW. |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine, CA 92714 |
| Contact | Alex Gerwer |
| Correspondent | Alex Gerwer NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine, CA 92714 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-24 |
| Decision Date | 1990-01-19 |