The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Electronic Spirometer Model Mfr-8100.
| Device ID | K810712 |
| 510k Number | K810712 |
| Device Name: | ELECTRONIC SPIROMETER MODEL MFR-8100 |
| Classification | Calculator, Predicted Values, Pulmonary Function |
| Applicant | NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601 |
| Product Code | BTY |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-17 |
| Decision Date | 1981-03-24 |