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510(k) K822414

TRACOR RA400 AUDIOMETER by Tracor Instruments, Inc. — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1982
Date Received
August 11, 1982
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)
  • K790903 — TRACOR MODEL RA-411 MICROPROCESSOR (May 31, 1979)
  • K781704 — STIMULATOR, TN-3001 SOMATOSENSORY (December 1, 1978)
  • K781743 — RESPONSE SYSTEM, TN-3000 (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)
  • K760859 — TRACOR MODEL RA 208 COMPLIANCE AUDIOM (October 29, 1976)

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  • K151025 — iHearTest (December 29, 2015)