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510(k) K770279

MONITOR, PORTABLE, PART #431-010 by Mennen Greatbatch Electonics — Product Code DXJ

K770279 is an FDA 510(k) premarket notification submitted by Mennen Greatbatch Electonics for the device "MONITOR, PORTABLE, PART #431-010". The FDA issued a decision of Substantially Equivalent on February 24, 1977. The device falls under product code DXJ (Display, Cathode-Ray Tube, Medical), a Class II device regulated under 21 CFR 870.2450. Mennen Greatbatch Electonics has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1977
Date Received
February 14, 1977
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 Mennen Greatbatch Electonics

  • K772000 — ECG TELEMETRY SYSTEM (November 22, 1977)
  • K770832 — PORTASCOPE II (June 3, 1977)
  • K770247 — D.C. AMPLIFIER MODULE (February 14, 1977)
  • K770246 — ISOLATED EEG AMPLIFIER MODULE (February 14, 1977)
  • K770245 — ABDOMINAL FETAL ECG MODULE (February 14, 1977)

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