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510(k) K864278

DS-II DIGITAL SONOGRAPHY SYSTEM by Intl. Acoustics, Inc. — Product Code DQD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1987
Date Received
October 30, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stethoscope, Electronic
Device Class
Class II
Regulation Number
870.1875
Review Panel
CV
Submission Type

Other clearances by Intl. Acoustics, Inc.

  • K873640 — MODIFIED DSP100 AMPLIFIER (December 7, 1987)
  • K864429 — DSP100 CAROTID PHONOANGIOGRAPHY MODULE (May 12, 1987)
  • K860814 — DSP100 AMPLIFIER (December 5, 1986)
  • K844997 — IAI PROGRAM-COMPUTER PROGRAM (April 9, 1985)

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