The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Nihon Kohden Blood Flowmeters #mfv-1100.
| Device ID | K820742 |
| 510k Number | K820742 |
| Device Name: | NIHON KOHDEN BLOOD FLOWMETERS #MFV-1100 |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-18 |
| Decision Date | 1982-04-15 |