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510(k) K870545

ANDRIES PHYSICAL ASSESSMENT COMPUTER by Andries Tek, Inc. — Product Code DQC

K870545 is an FDA 510(k) premarket notification submitted by Andries Tek, Inc. for the device "ANDRIES PHYSICAL ASSESSMENT COMPUTER". The FDA issued a decision of Substantially Equivalent on August 14, 1987. The device falls under product code DQC (Phonocardiograph), a Class I device regulated under 21 CFR 870.2390.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1987
Date Received
February 10, 1987
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 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)
  • K864429 — DSP100 CAROTID PHONOANGIOGRAPHY MODULE (May 12, 1987)
  • K860814 — DSP100 AMPLIFIER (December 5, 1986)

FDA data resources