The following data is part of a premarket notification filed by Bio-logic Systems Corp. with the FDA for Bio-logic Insert Earphones.
| Device ID | K031352 |
| 510k Number | K031352 |
| Device Name: | BIO-LOGIC INSERT EARPHONES |
| Classification | Audiometer |
| Applicant | BIO-LOGIC SYSTEMS CORP. ONE BIO-LOGIC PLAZA Mundelein, IL 60060 -3700 |
| Contact | Erik C Gundersen |
| Correspondent | Erik C Gundersen 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 | 2003-04-29 |
| Decision Date | 2003-07-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830053341 | K031352 | 000 |
| 00382830001038 | K031352 | 000 |
| 00382830001007 | K031352 | 000 |
| 00382830000826 | K031352 | 000 |
| 00382830000819 | K031352 | 000 |
| 00382830000796 | K031352 | 000 |
| 00382830000772 | K031352 | 000 |
| 00382830000765 | K031352 | 000 |
| 00382830000758 | K031352 | 000 |
| 00382830052191 | K031352 | 000 |
| 00382830052207 | K031352 | 000 |
| 00382830053334 | K031352 | 000 |
| 00382830053327 | K031352 | 000 |
| 00382830052504 | K031352 | 000 |
| 00382830052467 | K031352 | 000 |
| 00382830052313 | K031352 | 000 |
| 00382830052306 | K031352 | 000 |
| 00382830052290 | K031352 | 000 |
| 00382830052214 | K031352 | 000 |
| 00382830000741 | K031352 | 000 |