The following data is part of a premarket notification filed by Gould, Inc. with the FDA for Model 2120 Spiroscreen.
| Device ID | K854403 |
| 510k Number | K854403 |
| Device Name: | MODEL 2120 SPIROSCREEN |
| Classification | Spirometer, Diagnostic |
| Applicant | GOULD, INC. 805 LIBERTY LN. Dayton, OH 45449 |
| Contact | Paul L Kittinger |
| Correspondent | Paul L Kittinger GOULD, INC. 805 LIBERTY LN. Dayton, OH 45449 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-31 |
| Decision Date | 1986-01-14 |