The following data is part of a premarket notification filed by Bio-logic Systems Corp. with the FDA for Addition Of Built-in Oxymeter To Sleepscan Prod..
| Device ID | K930790 |
| 510k Number | K930790 |
| Device Name: | ADDITION OF BUILT-IN OXYMETER TO SLEEPSCAN PROD. |
| Classification | Monitor, Breathing Frequency |
| Applicant | BIO-LOGIC SYSTEMS CORP. ONE BIO-LOGIC PLAZA Mundelein, IL 60060 -3700 |
| Contact | Cathy Buhner |
| Correspondent | Cathy Buhner BIO-LOGIC SYSTEMS CORP. ONE BIO-LOGIC PLAZA Mundelein, IL 60060 -3700 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-16 |
| Decision Date | 1994-01-06 |