The following data is part of a premarket notification filed by Devilbiss Health Care, Inc. with the FDA for Oxygen Sensing Device, Modification.
| Device ID | K913392 |
| 510k Number | K913392 |
| Device Name: | OXYGEN SENSING DEVICE, MODIFICATION |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| Applicant | DEVILBISS HEALTH CARE, INC. 1200 EAST MAIN ST. P.O.BOX 635 Somerset, PA 15501 -0635 |
| Contact | David L Gast |
| Correspondent | David L Gast DEVILBISS HEALTH CARE, INC. 1200 EAST MAIN ST. P.O.BOX 635 Somerset, PA 15501 -0635 |
| Product Code | CCL |
| CFR Regulation Number | 868.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-29 |
| Decision Date | 1992-07-17 |