The following data is part of a premarket notification filed by Etymotic Research with the FDA for Er-7c Clinical Probe Microphone.
| Device ID | K861113 |
| 510k Number | K861113 |
| Device Name: | ER-7C CLINICAL PROBE MICROPHONE |
| Classification | Calibrator, Hearing Aid / Earphone And Analysis Systems |
| Applicant | ETYMOTIC RESEARCH 61 MARTIN LN. Elk Grove Village, IL 60007 |
| Contact | Edwin L Devilbise |
| Correspondent | Edwin L Devilbise ETYMOTIC RESEARCH 61 MARTIN LN. Elk Grove Village, IL 60007 |
| Product Code | ETW |
| CFR Regulation Number | 874.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-25 |
| Decision Date | 1986-04-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00846430004955 | K861113 | 000 |
| 00846430004948 | K861113 | 000 |
| 00846430004931 | K861113 | 000 |
| 00846430004726 | K861113 | 000 |
| 00846430004719 | K861113 | 000 |
| 00846430004597 | K861113 | 000 |