The following data is part of a premarket notification filed by Etymotic Research with the FDA for Elec-tip.
| Device ID | K873298 |
| 510k Number | K873298 |
| Device Name: | ELEC-TIP |
| Classification | Electrode, Cutaneous |
| Applicant | ETYMOTIC RESEARCH 61 MARTIN LN. Elk Grove Village, IL 60007 |
| Contact | Edwin L Devilbiss |
| Correspondent | Edwin L Devilbiss ETYMOTIC RESEARCH 61 MARTIN LN. Elk Grove Village, IL 60007 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-18 |
| Decision Date | 1987-11-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00846430005372 | K873298 | 000 |
| 00846430004818 | K873298 | 000 |
| 00846430004061 | K873298 | 000 |
| 00846430004047 | K873298 | 000 |