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510(k) K953472

NELLCOR SYMPHONY N-3100 BLOOD PRESSURE MONITOR by Nellcor, Inc. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1995
Date Received
July 24, 1995
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 Nellcor, Inc.

  • K952316 — NELLCOR SYMPHONY N-3000 PULSE OXIMETER (August 17, 1995)
  • K952222 — NELLCOR N-20PA PORTABLE PULSE OXIMETER (August 15, 1995)
  • K942347 — NELLCOR SYMPHONY PULSE OXIMETER MODEL N-3000 (May 12, 1995)
  • K945947 — NELLCOR SYMPHONY(TM) N-3100 BLOOD PRESSURE MONITOR AND CONNECTED TO THE NELLCOR (March 8, 1995)
  • K944760 — DURA-Y OXYGEN TRANSDUCER, EAR CLIP (October 17, 1994)
  • K944400 — PEDI-CAP (September 27, 1994)
  • K915494 — NELLCOR STAT-CAP AIRWAY CO2 INDICATOR, MODEL N-60 (August 6, 1993)
  • K915699 — NELLCOR PORTABLE PULSE OXIMETER MODEL N-20 (May 27, 1993)
  • K913695 — NELLCOR(R) N-180 PULSE OXIMETER (November 13, 1991)
  • K904039 — REFLECTANCE SENSOR (RS-10) (December 27, 1990)

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