The following data is part of a premarket notification filed by Fukuda Denshi Usa, Inc. with the FDA for Modified Spiroscan 1000.
| Device ID | K897094 |
| 510k Number | K897094 |
| Device Name: | MODIFIED SPIROSCAN 1000 |
| Classification | Spirometer, Diagnostic |
| Applicant | FUKUDA DENSHI USA, INC. 7102-A 180TH AVENUE NORTHEAST Redmond, WA 98052 |
| Contact | Robert J Steurer |
| Correspondent | Robert J Steurer 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 | 1989-12-20 |
| Decision Date | 1990-01-12 |