FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTERACOUSTICS AUTOMATIC IMPEDANCE AUDIOMETER
K Number: K942008
·
Decision Aug 24, 1994
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
69
Applicant Total
9
Review Days
121
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Basic Information
- Device Name
- INTERACOUSTICS AUTOMATIC IMPEDANCE AUDIOMETER
- K Number
- K942008
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.1090
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Precision Acoustics Ind., Inc.
- Date Received
- April 25, 1994
- Decision Date
- August 24, 1994
- Product Code
- ETY
- 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 |
|---|---|---|---|
| ETY | Tester, Auditory Impedance | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
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Other Clearances by Precision Acoustics Ind., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K943607 | INTERACOUSTICS HEARING AID ANALYZER MS 40 | Sep 23, 1994 | Substantially Equivalent |
| K941920 | INTERACOUSTICS CLINICAL AUDIOMETER | Sep 16, 1994 | Substantially Equivalent |
| K943066 | INTERACOUSTICS COMPUTER AUDIOMETER BA 20 | Aug 24, 1994 | Substantially Equivalent |
| K942007 | INTERACOUSTICS CLINICAL IMPEDANCE AUDIOMETER AZ26 | Aug 24, 1994 | Substantially Equivalent |
| K943065 | INTERACOUSTICS CLINICAL AUDIOMETER | Aug 17, 1994 | Substantially Equivalent |
| K942006 | INTERACOUSTICS DIAGNOSTIC AUDIOMETER | Jun 20, 1994 | Substantially Equivalent |
| K941848 | INTERACOUSTICS. HEARING AID ANALYZER | May 23, 1994 | Substantially Equivalent |
| K930260 | ACOUSTIC ANALYZER AA30 | Jul 13, 1993 | Substantially Equivalent |