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510(k) K770757

PULSE/PHONOCARDIOGRAPHY CHANNEL, 144 by Honeywell, Inc. — Product Code DQC

K770757 is an FDA 510(k) premarket notification submitted by Honeywell, Inc. for the device "PULSE/PHONOCARDIOGRAPHY CHANNEL, 144". The FDA issued a decision of Substantially Equivalent on May 9, 1977. The device falls under product code DQC (Phonocardiograph), a Class I device regulated under 21 CFR 870.2390. Honeywell, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1977
Date Received
April 25, 1977
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 Honeywell, Inc.

  • K902230 — COLORADO COLOR IMAGING RECORDER (June 19, 1990)
  • K863100 — CEN STA MON AC/DC ALARM CENTRAL ACCES ALARM RECOR (February 3, 1987)
  • K853501 — HONEYWELL ELECTRONIC VENTILATOR EV-A (April 4, 1986)
  • K855125 — PHYSIOLOGICAL TELEMETRY PATIENT MONITORING SYSTEM (March 26, 1986)
  • K851888 — APM DISPOS. BLOOD PRESSURE TRANSDUCER (August 6, 1985)
  • K851496 — ECG MONITOR MODEL RM102 (July 24, 1985)
  • K850794 — PATIENT MONITOR MODEL RM-300 (April 18, 1985)
  • K851092 — PORTABLE DEFIBRILLATOR/MONITOR ED 425 (April 10, 1985)
  • K834530 — EXTENSION BOX EB200 (June 1, 1984)
  • K834282 — ULTRA IMAGER 2000 (April 23, 1984)

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