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510(k) K862026

HA-2000 REAL EAR SPECTROSCOPE by And/Or Corp. — Product Code ETW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1986
Date Received
May 28, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Hearing Aid / Earphone And Analysis Systems
Device Class
Class II
Regulation Number
874.3310
Review Panel
EN
Submission Type

Other clearances by And/Or Corp.

  • K851143 — RHINOMANOMETERS NR3, NR4 (May 23, 1985)

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  • K050496 — REM440 (April 29, 2005)
  • K041853 — OTOGRAM (September 3, 2004)
  • K022510 — FONIX, MODEL 7000 (August 27, 2002)
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