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510(k) K790198

MONITOR PLUG-IN MODEL M1106 ECG by Electronics For Medicine, Inc. — Product Code DRT

K790198 is an FDA 510(k) premarket notification submitted by Electronics For Medicine, Inc. for the device "MONITOR PLUG-IN MODEL M1106 ECG". The FDA issued a decision of Substantially Equivalent on March 6, 1979. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Electronics For Medicine, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1979
Date Received
January 25, 1979
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 Electronics For Medicine, Inc.

  • K830791 — UNIVERSAL MEDDARS SYSTEM (June 22, 1983)
  • K830795 — CABINET FOR MULTIPLE FUNCTION BLOCKS (May 18, 1983)
  • K792528 — RESPIRATION/APNEA AMPLIFIER MODEL 3105 (February 21, 1980)
  • K791006 — SMART BILECTRODES (June 11, 1979)
  • K790203 — INTERVAL TIMER MODEL V4295 (March 2, 1979)
  • K790185 — MODEL V 4207 INTEGRATING PLUG-IN (February 16, 1979)
  • K780107 — ANALYZER-PLUG-IN, CO2 MODEL M 3104 (January 30, 1978)
  • K770366 — ISOLATED ELECTROCARDIOGRAPH MODEL 1207 (March 1, 1977)

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