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510(k) K896528

SFA MODULE by Life Sciences Manufacturing, Inc. — Product Code DXG

K896528 is an FDA 510(k) premarket notification submitted by Life Sciences Manufacturing, Inc. for the device "SFA MODULE". The FDA issued a decision of Substantially Equivalent on January 26, 1990. The device falls under product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function), a Class II device regulated under 21 CFR 870.1435. Life Sciences Manufacturing, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1990
Date Received
November 16, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Pre-Programmed, Single-Function
Device Class
Class II
Regulation Number
870.1435
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)
  • 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 DXG

  • K253092 — Argos Infinity (Rev. 1.0) (February 13, 2026)
  • K251275 — VitalStream ART Connect; VitalStream-Hemo (September 26, 2025)
  • K232048 — Cogent™ Hemodynamic Monitoring System; Cogent™ HMS (December 20, 2023)
  • K212529 — Hypotension Decision Assist Model HDA-OR2 (November 23, 2021)
  • K192169 — PulsioFlex Monitoring System with ProAQT Sensor (April 30, 2020)
  • K193179 — EV1000 Clinical Platform (December 17, 2019)
  • K190955 — Hypotension Decision Assist (November 27, 2019)
  • K181372 — Argos (December 13, 2018)
  • K172259 — PulsioFlex Monitoring System (January 18, 2018)
  • K163334 — LiDCOunity v2 Hemodynamic Monitor (June 5, 2017)

FDA data resources