The following data is part of a premarket notification filed by Bio-logic Systems Corp. with the FDA for Scout Sport Otoacoustic Emissions Measurement System.
| Device ID | K121512 |
| 510k Number | K121512 |
| Device Name: | SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM |
| Classification | Audiometer |
| Applicant | BIO-LOGIC SYSTEMS CORP. ONE BIOLOGIC PLAZA Mundelein, IL 60060 |
| Contact | Don Williams |
| Correspondent | Don Williams BIO-LOGIC SYSTEMS CORP. ONE BIOLOGIC PLAZA Mundelein, IL 60060 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-21 |
| Decision Date | 2012-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830055031 | K121512 | 000 |
| 00382830001618 | K121512 | 000 |