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510(k) K781535

AC ADAPTER:MODELS 9525,9526,9527 by Edwards Laboratories — Product Code DXG

K781535 is an FDA 510(k) premarket notification submitted by Edwards Laboratories for the device "AC ADAPTER:MODELS 9525,9526,9527". The FDA issued a decision of Substantially Equivalent on September 15, 1978. The device falls under product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function), a Class II device regulated under 21 CFR 870.1435. Edwards Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1978
Date Received
September 6, 1978
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 Edwards Laboratories

  • K801552 — MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR (July 28, 1980)
  • K800655 — MODEL 100 SPECTRAVIEW (April 16, 1980)
  • K792441 — CARPENTIER-EDWARDS FLEX. ANNULOPLASTY (March 17, 1980)
  • K792034 — INTEGRAL DISPOSABLE HOLDER CARPENTIER (December 7, 1979)
  • K790047 — CARDIAC OUTPUT COMPUTER, MDEL 9520A (February 26, 1979)
  • K790022 — DISPOSABLE HOLDER FOR BIOPROSTHESIS (January 15, 1979)
  • K771663 — PROBE & CATHETER (September 20, 1977)
  • K771046 — VENA CAVA UMBRELLA FILTER, MODEL 7321 (June 22, 1977)
  • K760151 — APPLICATOR,ANGIOGRAPHY (7310MOBIN-UDDIN) (August 26, 1976)
  • K760192 — COMPUTER, THERMODILUTION CARDIAC (9520) (July 19, 1976)

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