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510(k) K844997

IAI PROGRAM-COMPUTER PROGRAM by Intl. Acoustics, Inc. — Product Code DXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1985
Date Received
December 26, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Pre-Programmed, Single-Function
Device Class
Class II
Regulation Number
870.1435
Review Panel
CV
Submission Type

Other clearances by Intl. Acoustics, Inc.

  • K873640 — MODIFIED DSP100 AMPLIFIER (December 7, 1987)
  • K864278 — DS-II DIGITAL SONOGRAPHY SYSTEM (June 10, 1987)
  • K864429 — DSP100 CAROTID PHONOANGIOGRAPHY MODULE (May 12, 1987)
  • K860814 — DSP100 AMPLIFIER (December 5, 1986)

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