The following data is part of a premarket notification filed by Sensormedics Corp. with the FDA for Sensormedics Model 2200 Pulmonary Function Labs.
| Device ID | K923988 |
| 510k Number | K923988 |
| Device Name: | SENSORMEDICS MODEL 2200 PULMONARY FUNCTION LABS |
| Classification | Spirometer, Diagnostic |
| Applicant | SENSORMEDICS CORP. 22705 SAVI RANCH PKWY. Yorba Linda, CA 92887 -4645 |
| Contact | Paul L Kittinger |
| Correspondent | Paul L Kittinger SENSORMEDICS CORP. 22705 SAVI RANCH PKWY. Yorba Linda, CA 92887 -4645 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-10 |
| Decision Date | 1993-10-21 |