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510(k) K761057

ARTERIOSONDE BLOOD PRESS. MNTR. (#1020) by Roche Medical Electronics, Inc. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1976
Date Received
November 18, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
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)
  • K791036 — FETASONDE UTERINE WORK MONITOR (September 4, 1979)
  • K791035 — FETASONDE FETAL ACTIVITY 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)
  • K782088 — MONITOR, HEART RATE MODEL 105 (January 4, 1979)

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