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510(k) K834600

RECOMB ECG PREAMPLIFIER/206 069 03 by Litton Medical Electronics — Product Code DRT

K834600 is an FDA 510(k) premarket notification submitted by Litton Medical Electronics for the device "RECOMB ECG PREAMPLIFIER/206 069 03". The FDA issued a decision of Substantially Equivalent on June 1, 1984. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Litton Medical Electronics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 1984
Date Received
December 30, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

Other clearances by Litton Medical Electronics

  • K840522 — RECOMED BLOOD-FLOW METER H236-052-02 (May 16, 1985)
  • K840439 — RECOMED CARDIAC OUTPUT METER 236067- (November 20, 1984)
  • K840899 — SERVOMED ARRHYCOMP CENTRAL MONITOR SYS (November 20, 1984)
  • K840523 — SERVOMED PULSE AMPLIFIER MODULE-206- (October 29, 1984)
  • K840524 — SERVOMED BASIC BEDSIDE UNIT SMV 110TP (October 26, 1984)
  • K840832 — SERVOMED OXCARDIORE SPIROGRAPH 324/111 (September 20, 1984)
  • K840209 — SERVOMED MEDIVISION SCOPE SMV-235 (September 20, 1984)
  • K832998 — 2-CHANNEL RECORDER (June 1, 1984)
  • K840521 — SERVOMED DIGITAL DISPLAY MODULE (June 1, 1984)
  • K840525 — SERVOMED COMPACT MONITOR SMK 155-1/101 (June 1, 1984)

Other clearances for product code DRT

  • K261286 — The Circadia C300 System (C300) (May 20, 2026)
  • K252676 — The Circadia C300 System (C300) (February 3, 2026)
  • K253388 — Sleepiz One+ (Model 2.5) (January 28, 2026)
  • K251364 — Sleepiz One+ (2.5) (July 29, 2025)
  • K234003 — The Circadia C200 System (May 30, 2024)
  • K232354 — Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central (March 22, 2024)
  • K231733 — Neteera 130H-Plus Vital Sign Monitoring Sensor (February 9, 2024)
  • K223163 — Sleepiz One+ (August 18, 2023)
  • K212143 — Neteera 130H/131H Vital Sign Monitoring Sensor (September 28, 2022)
  • K202138 — Cardiac Trigger Monitor (May 14, 2021)

FDA data resources