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510(k) K896500

CWD/PPG MODULE by Life Sciences Manufacturing, Inc. — Product Code JOM

K896500 is an FDA 510(k) premarket notification submitted by Life Sciences Manufacturing, Inc. for the device "CWD/PPG MODULE". The FDA issued a decision of Substantially Equivalent on July 18, 1990. The device falls under product code JOM (Plethysmograph, Photoelectric, Pneumatic Or Hydraulic), a Class II device regulated under 21 CFR 870.2780. Life Sciences Manufacturing, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1990
Date Received
November 14, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Device Class
Class II
Regulation Number
870.2780
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)
  • 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)
  • K832679 — NON-INVASIVE CLINICAL VASCULAR LAB (January 3, 1984)
  • K822522 — CUTANEOUS PRESSURE PLETHYSMOGRAPH (September 28, 1982)
  • K811560 — AUTOMATED PHYSIOLOGIC PROFILE MONITOR (June 18, 1981)

Other clearances for product code JOM

  • K220527 — PADnet Xpress (October 20, 2022)
  • K213730 — MESI mTABLET TBI diagnostic system, MESI mTABLET TBI (April 21, 2022)
  • K200567 — ASI Plethysmogrpah Analyzer (February 26, 2021)
  • K201046 — Automated ankle brachial pressure index measuring device, MESI mTABLET system (December 11, 2020)
  • K191266 — VitalScan ANS (January 15, 2020)
  • K172655 — Automated ankle brachial pressure index measuring device (January 11, 2018)
  • K173696 — TBL-ABI System (December 19, 2017)
  • K143152 — TM-ABI system (July 22, 2015)
  • K143094 — QuantaFlo (March 5, 2015)
  • K123921 — BODYTRONIC 200 (April 26, 2013)

FDA data resources