The following data is part of a premarket notification filed by Sensormedics Corp. with the FDA for Sensormedics Oxyshuttle Ii(tm).
| Device ID | K913790 |
| 510k Number | K913790 |
| Device Name: | SENSORMEDICS OXYSHUTTLE II(TM) |
| Classification | Oximeter |
| Applicant | SENSORMEDICS CORP. 22705 SAVI RANCH PKWY. Yorba Linda, CA 92887 -4645 |
| Contact | David M Trueblood |
| Correspondent | David M Trueblood SENSORMEDICS CORP. 22705 SAVI RANCH PKWY. Yorba Linda, CA 92887 -4645 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-23 |
| Decision Date | 1992-02-26 |