The following data is part of a premarket notification filed by Fukuda Denshi Usa, Inc. with the FDA for Fukuda Denshi Model Spirosift Sp-5000.
| Device ID | K922428 |
| 510k Number | K922428 |
| Device Name: | FUKUDA DENSHI MODEL SPIROSIFT SP-5000 |
| Classification | Spirometer, Diagnostic |
| Applicant | FUKUDA DENSHI USA, INC. 7102-A 180TH AVENUE NORTHEAST Redmond, WA 98052 |
| Contact | David J Geraghty |
| Correspondent | David J Geraghty FUKUDA DENSHI USA, INC. 7102-A 180TH AVENUE NORTHEAST Redmond, WA 98052 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-22 |
| Decision Date | 1993-01-15 |