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510(k) K760859

TRACOR MODEL RA 208 COMPLIANCE AUDIOM by Tracor Instruments, Inc. — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 1976
Date Received
October 18, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Audiometer
Device Class
Class II
Regulation Number
874.1050
Review Panel
EN
Submission Type

Other clearances by Tracor Instruments, Inc.

  • K853245 — TRACOR MODEL RA600 MICROPROCESSOR AUDIOMETER (October 16, 1985)
  • K851392 — TRACOR 200 MICROPROCESSOR AUDIOMETER/TRACOR RA 200 (June 20, 1985)
  • K822414 — TRACOR RA400 AUDIOMETER (August 30, 1982)
  • K790903 — TRACOR MODEL RA-411 MICROPROCESSOR (May 31, 1979)
  • K781743 — RESPONSE SYSTEM, TN-3000 (December 1, 1978)
  • K781704 — STIMULATOR, TN-3001 SOMATOSENSORY (December 1, 1978)
  • K780749 — SPEECH AUDIOMETER RA 226 (May 16, 1978)
  • K780474 — AUDIOMETER CALIBRATOR MODEL RA 310 (March 30, 1978)
  • K780450 — TRACOR RA 410 AUDIOMETER (March 30, 1978)

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  • K172403 — GSI Novus (October 20, 2017)
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  • K151025 — iHearTest (December 29, 2015)