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510(k) K895534

BIOLOG by Micromedical — Product Code DRT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1990
Date Received
September 13, 1989
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 Micromedical

  • K974352 — CARDIOVIEW 3000 SOFTWARE (September 8, 1998)
  • K974220 — MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE (August 25, 1998)
  • K974351 — BIOLOG 3000 ELECTROCARDIOGRAPH (April 1, 1998)
  • K970305 — PRINTER INTERFACE (August 15, 1997)
  • K955891 — CARDIOVIEW TRANSTELEPHONIC SOFTWARE (October 8, 1996)
  • K895535 — PACEVIEW (March 19, 1990)

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  • 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)
  • K202464 — Vital Sign Monitoring Sensor (Model :XK300) (April 26, 2021)