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510(k) K832679

NON-INVASIVE CLINICAL VASCULAR LAB by Life Sciences Manufacturing, Inc. — Product Code DQC

K832679 is an FDA 510(k) premarket notification submitted by Life Sciences Manufacturing, Inc. for the device "NON-INVASIVE CLINICAL VASCULAR LAB". The FDA issued a decision of Substantially Equivalent on January 3, 1984. The device falls under product code DQC (Phonocardiograph), a Class I device regulated under 21 CFR 870.2390. Life Sciences Manufacturing, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1984
Date Received
August 9, 1983
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 Life Sciences Manufacturing, Inc.

  • K910905 — SFA-II MICROPROCESSOR-CONTROLLED MODULE (July 24, 1991)
  • K903700 — IPG-II MODULE (January 16, 1991)
  • K896500 — CWD/PPG MODULE (July 18, 1990)
  • K900365 — PAG MICROPROCESSOR-CONTROLLED MODULE (July 18, 1990)
  • K895588 — PORTABLE AIR PLETHYSMOGRAPH (March 27, 1990)
  • K896528 — SFA MODULE (January 26, 1990)
  • K884624 — MVL/MODULAB WITH PVR MODULE (February 1, 1989)
  • K873041 — A-V RECORDER (February 4, 1988)
  • K822522 — CUTANEOUS PRESSURE PLETHYSMOGRAPH (September 28, 1982)
  • K811560 — AUTOMATED PHYSIOLOGIC PROFILE MONITOR (June 18, 1981)

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