510(k) K813557
- Device
- AUDITORY STIMULATOR
- Applicant
- WESTERN ADVANCED TECHNOLOGY, INC.
- 510(k) number
- K813557
- Product code
- ETS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-01-19
- Date received
- 1981-12-22
- Regulation
- 874.1120
- Classification name
- Generator, Electronic Noise (for Audiometric Testing)
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ETS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K811772 | AUDITORY LOCALIZER | Western Advanced Technology, Inc. | 1981-07-15 |
| K811790 | OCTOTOXIC SCREENER | Western Advanced Technology, Inc. | 1981-07-15 |
| K790064 | TINNITUS DEVICES | Vicon Instrument Co. | 1979-02-16 |
| K771188 | REVERSING CLICK GENERATOR RCG6 | Teca, Inc. | 1977-07-14 |
Legacy Summary#
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FDA Review#
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