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510(k) K851628

RMG-9 9 REMOTE MONITOR ACCESS. FOR G-2000 ELECTRO by Eaton Medical Group — Product Code DXJ

K851628 is an FDA 510(k) premarket notification submitted by Eaton Medical Group for the device "RMG-9 9 REMOTE MONITOR ACCESS. FOR G-2000 ELECTRO". The FDA issued a decision of Substantially Equivalent on June 27, 1985. The device falls under product code DXJ (Display, Cathode-Ray Tube, Medical), a Class II device regulated under 21 CFR 870.2450. Eaton Medical Group has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1985
Date Received
April 18, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Display, Cathode-Ray Tube, Medical
Device Class
Class II
Regulation Number
870.2450
Review Panel
CV
Submission Type

Other clearances by Eaton Medical Group

  • K851623 — MODEL TRC-40 TELEMETRY RECIEVER MODULE (January 22, 1986)
  • K851624 — MODEL TT-185 TELEMETRY TRANSMITTER (January 14, 1986)
  • K851625 — SCX-10 SINGLE CHANNEL RECORDER ACCESS. FOR G-2000 (November 19, 1985)
  • K851627 — KBX-20 OUTBOARD KEYBOARD ACCESS. FOR G-2000 ELECTR (November 8, 1985)
  • K851632 — PCX-100 PATIENT INPUT LEADWIRE (November 8, 1985)
  • K851631 — TMX-C1/C2 TRADMILL CONTROLLER ACCESS. (July 15, 1985)
  • K851630 — TMX-80 TREADMILL (July 9, 1985)
  • K851629 — TMX-70 TREADMILL (July 9, 1985)
  • K851633 — CC-100 CLOCK/CALANDER MODULE ACCESS. FOR G-2000 EL (June 26, 1985)
  • K851626 — SCX-35 THREE CHANNEL ACCESS. FOR MODULE G-2000 ELE (June 26, 1985)

Other clearances for product code DXJ

  • K212003 — ESSENZ Patient Monitor (November 10, 2021)
  • K212208 — Philips IntelliVue GuardianSoftware (Rev. E.0X) (September 30, 2021)
  • K201162 — Essence 55SP Large Monitor System (August 27, 2020)
  • K173107 — Vios Central Station Monitor Software, Vios Central Server Software (July 26, 2018)
  • K180534 — Philips IntelliVue GuardianSoftware (July 16, 2018)
  • K173381 — Nexxis OR (February 22, 2018)
  • K172969 — Essence 55S Large Monitor System (January 26, 2018)
  • K170460 — Sorin Connect (June 8, 2017)
  • K170537 — Nexxis OR, Nexxis (April 21, 2017)
  • K161880 — NIVR58-T kit (March 14, 2017)

FDA data resources