The following data is part of a premarket notification filed by Spirometrics, Inc. with the FDA for Spirometrics Breon 2400 & Smi 2400.
| Device ID | K831497 |
| 510k Number | K831497 |
| Device Name: | SPIROMETRICS BREON 2400 & SMI 2400 |
| Classification | Spirometer, Diagnostic |
| Applicant | SPIROMETRICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-10 |
| Decision Date | 1983-06-24 |