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510(k) K943726

ACOUSTIC RECORDER by Technology Applications Assoc., Inc. — Product Code DQC

K943726 is an FDA 510(k) premarket notification submitted by Technology Applications Assoc., Inc. for the device "ACOUSTIC RECORDER". The FDA issued a decision of Substantially Equivalent on November 30, 1994. 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
November 30, 1994
Date Received
August 2, 1994
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)
  • 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)
  • K860814 — DSP100 AMPLIFIER (December 5, 1986)

FDA data resources