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510(k) K904318

LOCAL REPORT GENERATOR by Spacelabs, Inc. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1990
Date Received
September 20, 1990
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 Spacelabs, Inc.

  • K954962 — SPACELABS MEDICAL MULTIGAS ANALYZER (May 31, 1996)
  • K951605 — SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM (July 14, 1995)
  • K950779 — HEART RATE VARIABILITY SOFTWARE OPTION (April 25, 1995)
  • K941165 — COMET CAPNOGRAPH MODULE (October 6, 1994)
  • K923788 — SPACE LABS MODEL 90560 (December 6, 1993)
  • K912742 — ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE (April 20, 1992)
  • K913038 — SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION (October 4, 1991)
  • K905065 — DEFIBRILLATOR LEAD ADAPTER (April 12, 1991)
  • K910029 — PATIENT CARE MANAGEMENT SYSTEM MODIFICATION (January 31, 1991)
  • K896903 — FIRST MEDIC MODEL 510 (December 27, 1990)

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