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510(k) K902185

DYNAMIC SPECTRAL PHONOCARDIOGRAPH by Reeves Scientific, Inc. — Product Code DQC

K902185 is an FDA 510(k) premarket notification submitted by Reeves Scientific, Inc. for the device "DYNAMIC SPECTRAL PHONOCARDIOGRAPH". The FDA issued a decision of Substantially Equivalent on March 25, 1991. 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
March 25, 1991
Date Received
May 14, 1990
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)
  • 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