Home / 510(k) Clearances / K953472

510(k) K953472

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

K953472 is an FDA 510(k) premarket notification submitted by Nellcor, Inc. for the device "NELLCOR SYMPHONY N-3100 BLOOD PRESSURE MONITOR". The FDA issued a decision of Substantially Equivalent on October 20, 1995. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Nellcor, Inc. has at least 10 other 510(k) clearances on record.

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)

Other clearances for product code DXN

  • K253126 — Wrist Blood Pressure Monitor (XW-05) (June 18, 2026)
  • K260693 — VicorderCS (VCS-SYS-1100) (June 16, 2026)
  • K253059 — Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08) (June 15, 2026)
  • K253124 — Upper arm electronic blood pressure monitor (XB-01) (June 3, 2026)
  • K253570 — Blood Pressure Monitor (W06LT) (May 20, 2026)
  • K254048 — Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19 (May 14, 2026)
  • K253152 — BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) (May 6, 2026)
  • K252501 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, D (April 28, 2026)
  • K260260 — Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521 (April 28, 2026)
  • K253982 — Korotkoff sound blood pressure monitor (April 21, 2026)

FDA data resources