The following data is part of a premarket notification filed by Bio-logic Systems Corp. with the FDA for Modification To Otoacoustic Emissions (oae0 Test Instrument.
| Device ID | K964132 |
| 510k Number | K964132 |
| Device Name: | MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT |
| Classification | Audiometer |
| Applicant | BIO-LOGIC SYSTEMS CORP. ONE BIO-LOGIC PLAZA Mundelein, IL 60060 -3700 |
| Contact | Norman E Brunner |
| Correspondent | Norman E Brunner BIO-LOGIC SYSTEMS CORP. ONE BIO-LOGIC PLAZA Mundelein, IL 60060 -3700 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-15 |
| Decision Date | 1997-05-13 |
| Summary: | summary |