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510(k) K782088

MONITOR, HEART RATE MODEL 105 by Roche Medical Electronics, Inc. — Product Code DRT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 1979
Date Received
December 14, 1978
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 Roche Medical Electronics, Inc.

  • K791559 — ROCHE SENSOR ADAPTOR (November 21, 1979)
  • K791039 — FETASONDE FETAL HEART RATE VARIABILITY (September 4, 1979)
  • K791037 — FETASONDE LABOR STATUS DISPLAY (September 4, 1979)
  • K791035 — FETASONDE FETAL ACTIVITY MONITOR (September 4, 1979)
  • K791036 — FETASONDE UTERINE WORK MONITOR (September 4, 1979)
  • K791038 — FETASONDE UTERINE ACTIVITY MONITOR (September 4, 1979)
  • K790761 — FETASONDE MODEL 2108 (June 1, 1979)
  • K790421 — ROCHE LACTATE ANALYZER 640 (May 15, 1979)
  • K782089 — MONITOR, HEART RATE MODEL 103 (January 4, 1979)
  • K781271 — MONITOR, PO2, INTRAVASCULAR (October 12, 1978)

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