The following data is part of a premarket notification filed by Sensor Medics Corp. with the FDA for Modification To Hiox.
| Device ID | K030943 |
| 510k Number | K030943 |
| Device Name: | MODIFICATION TO HIOX |
| Classification | Valve, Non-rebreathing |
| Applicant | SENSOR MEDICS CORP. 22705 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
| Contact | Earl W Draper |
| Correspondent | Earl W Draper SENSOR MEDICS CORP. 22705 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-26 |
| Decision Date | 2003-04-22 |
| Summary: | summary |