FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ER-7C CLINICAL PROBE MICROPHONE
K Number: K861113
·
Decision Apr 23, 1986
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
45
Applicant Total
8
Review Days
29
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Basic Information
- Device Name
- ER-7C CLINICAL PROBE MICROPHONE
- K Number
- K861113
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3310
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Etymotic Research
- Date Received
- March 25, 1986
- Decision Date
- April 23, 1986
- Product Code
- ETW
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ETW | Calibrator, Hearing Aid / Earphone And Analysis Systems | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
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FDA 510(k)
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Other Clearances by Etymotic Research
| K Number | Device Name | ||
|---|---|---|---|
| K011114 | ETYMOTIC RESEARCH ER-10D OAE PROBE | Jul 3, 2001 | Substantially Equivalent |
| K010165 | ERO SCAN OAE TEST SYSTEM | Mar 12, 2001 | Substantially Equivalent |
| K980533 | ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34) | Mar 23, 1998 | Substantially Equivalent |
| K930553 | CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT | Sep 29, 1993 | Substantially Equivalent |
| K930003 | TUBEPHONE MODELS ER-3A & ER-3 INSERT EARPHONES | Jun 18, 1993 | Substantially Equivalent |
| K873298 | ELEC-TIP | Nov 24, 1987 | Substantially Equivalent |
| K843144 | K-BASS LO FREQUENCY HEARING AID | Sep 7, 1984 | Substantially Equivalent |