Home / 510(k) Clearances / K945947

510(k) K945947

NELLCOR SYMPHONY(TM) N-3100 BLOOD PRESSURE MONITOR AND CONNECTED TO THE NELLCOR SYMPHONY(TM) N-3000 PULSE OXIMETER by Nellcor, Inc. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 1995
Date Received
December 6, 1994
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.

  • K953472 — NELLCOR SYMPHONY N-3100 BLOOD PRESSURE MONITOR (October 20, 1995)
  • 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)
  • 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)

Other clearances for product code DXN

  • K252779 — YUWELL® Electronic Blood Pressure Monitor (YE630CR) (March 5, 2026)
  • K253228 — YUWELL® Electronic Blood Pressure Monitor (YE650AR) (February 23, 2026)
  • K252685 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, (February 13, 2026)
  • K251581 — Wearable Ambulatory Blood Pressure Monitor (WBP-02A) (February 13, 2026)
  • K253133 — Wrist Blood Pressure Monitor (BPM-W1VL) (February 13, 2026)
  • K251307 — Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) (January 12, 2026)
  • K253142 — Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D) (January 9, 2026)
  • K251143 — Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L) (December 19, 2025)
  • K251331 — Blood Pressure Monitor (B73, BE23T) (October 27, 2025)
  • K251795 — Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753) (October 9, 2025)