FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRACOR MODEL RA600 MICROPROCESSOR AUDIOMETER
K Number: K853245
·
Decision Oct 16, 1985
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
234
Applicant Total
10
Review Days
76
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Basic Information
- Device Name
- TRACOR MODEL RA600 MICROPROCESSOR AUDIOMETER
- K Number
- K853245
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.1050
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Tracor Instruments, Inc.
- Date Received
- August 1, 1985
- Decision Date
- October 16, 1985
- Product Code
- EWO
- 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 |
|---|---|---|---|
| EWO | Audiometer | FDA class 2 | Ear, Nose, Throat |
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Other Clearances by Tracor Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K851392 | TRACOR 200 MICROPROCESSOR AUDIOMETER/TRACOR RA 200 | Jun 20, 1985 | Substantially Equivalent |
| K822414 | TRACOR RA400 AUDIOMETER | Aug 30, 1982 | Substantially Equivalent |
| K790903 | TRACOR MODEL RA-411 MICROPROCESSOR | May 31, 1979 | Substantially Equivalent |
| K781704 | STIMULATOR, TN-3001 SOMATOSENSORY | Dec 1, 1978 | Substantially Equivalent |
| K781743 | RESPONSE SYSTEM, TN-3000 | Dec 1, 1978 | Substantially Equivalent |
| K780749 | SPEECH AUDIOMETER RA 226 | May 16, 1978 | Substantially Equivalent |
| K780474 | AUDIOMETER CALIBRATOR MODEL RA 310 | Mar 30, 1978 | Substantially Equivalent |
| K780450 | TRACOR RA 410 AUDIOMETER | Mar 30, 1978 | Substantially Equivalent |
| K760859 | TRACOR MODEL RA 208 COMPLIANCE AUDIOM | Oct 29, 1976 | Substantially Equivalent |