The following data is part of a premarket notification filed by Sensormedics Corp. with the FDA for Sensormedics Model 2600 Pediatric Pulmoonary Cart.
| Device ID | K915833 |
| 510k Number | K915833 |
| Device Name: | SENSORMEDICS MODEL 2600 PEDIATRIC PULMOONARY CART |
| Classification | Calculator, Pulmonary Function Data |
| Applicant | SENSORMEDICS CORP. 22705 SAVI RANCH PKWY. Yorba Linda, CA 92887 -4645 |
| Contact | Paul Kittinger |
| Correspondent | Paul Kittinger SENSORMEDICS CORP. 22705 SAVI RANCH PKWY. Yorba Linda, CA 92887 -4645 |
| Product Code | BZC |
| CFR Regulation Number | 868.1880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-24 |
| Decision Date | 1992-12-02 |