The following data is part of a premarket notification filed by Sensormedics Corp. with the FDA for Sensormedics Oxyshuttle(tm).
| Device ID | K862617 |
| 510k Number | K862617 |
| Device Name: | SENSORMEDICS OXYSHUTTLE(TM) |
| Classification | Oximeter |
| Applicant | SENSORMEDICS CORP. 1630 S. STATE COLLEGE BLVD. Anaheim, CA 92806 |
| Contact | Merton A Robinson |
| Correspondent | Merton A Robinson SENSORMEDICS CORP. 1630 S. STATE COLLEGE BLVD. Anaheim, CA 92806 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-09 |
| Decision Date | 1986-09-26 |