The following data is part of a premarket notification filed by Sensor Medics Corp. with the FDA for Pulmonary Function System.
| Device ID | K842041 |
| 510k Number | K842041 |
| Device Name: | PULMONARY FUNCTION SYSTEM |
| Classification | Spirometer, Diagnostic |
| Applicant | SENSOR MEDICS CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-21 |
| Decision Date | 1984-06-15 |