The following data is part of a premarket notification filed by Sensormedics Corp. with the FDA for Sensormedics Model 2450 Pulmonary Function Lab..
| Device ID | K915848 |
| 510k Number | K915848 |
| Device Name: | SENSORMEDICS MODEL 2450 PULMONARY FUNCTION LAB. |
| Classification | Driver, Wire, And Bone Drill, Manual |
| 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 | DZJ |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-26 |
| Decision Date | 1992-10-28 |