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510(k) K860814

DSP100 AMPLIFIER by Intl. Acoustics, Inc. — Product Code DQC

K860814 is an FDA 510(k) premarket notification submitted by Intl. Acoustics, Inc. for the device "DSP100 AMPLIFIER". The FDA issued a decision of Substantially Equivalent on December 5, 1986. The device falls under product code DQC (Phonocardiograph), a Class I device regulated under 21 CFR 870.2390. Intl. Acoustics, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 1986
Date Received
March 4, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Phonocardiograph
Device Class
Class I
Regulation Number
870.2390
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)
  • K844997 — IAI PROGRAM-COMPUTER PROGRAM (April 9, 1985)

Other clearances for product code DQC

  • K950537 — CARDIOPHONICS INCORPORATED DPS 2000 PHONOCARDIOGRAPH (March 1, 1996)
  • K952651 — LIFE SOUND SENSOR (September 19, 1995)
  • K943726 — ACOUSTIC RECORDER (November 30, 1994)
  • K924054 — PHONOCARDIOGRAPH (January 22, 1993)
  • K902185 — DYNAMIC SPECTRAL PHONOCARDIOGRAPH (March 25, 1991)
  • K900560 — ACUSON HEARTSOUND/PULSE/RESPIRATION MODULE (December 3, 1990)
  • K900365 — PAG MICROPROCESSOR-CONTROLLED MODULE (July 18, 1990)
  • K873640 — MODIFIED DSP100 AMPLIFIER (December 7, 1987)
  • K870545 — ANDRIES PHYSICAL ASSESSMENT COMPUTER (August 14, 1987)
  • K864429 — DSP100 CAROTID PHONOANGIOGRAPHY MODULE (May 12, 1987)

FDA data resources