The following data is part of a premarket notification filed by Circadian, Inc. with the FDA for Pulmonary Function Testing Sts.
| Device ID | K840741 |
| 510k Number | K840741 |
| Device Name: | PULMONARY FUNCTION TESTING STS |
| Classification | Spirometer, Diagnostic |
| Applicant | CIRCADIAN, 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 | 1984-02-01 |
| Decision Date | 1984-03-05 |