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Finger and Ear Sensors and Neonatal-Adult and Adult/Pediatric Adhesive Sensors for Use with Nellcor R-Cal SPO2

by Measurement Specialties, Inc.

510(k) K061191

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK061191 Date22 May 2006ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DQA
Device Class
Class II
Regulation
21 CFR Part 870.2700
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

These sensors are designed for continuous, noninvasive functional arterial oxygen saturation and pulse rate monitoring. They are intended for use in adult, pediatric, and neonatal patients.

The device is authorized via FDA 510K. It is compatible for use with Nellcor R-Cal SpO2 systems.

Other devices from Measurement Specialties, Inc.

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of these sensors?

    These sensors are designed for the continuous, noninvasive monitoring of functional arterial oxygen saturation and pulse rate in patients ranging from neonates to adults.

  • Which monitoring systems are these sensors compatible with?

    These sensors are specifically engineered for use with Nellcor R-Cal SpO2 monitoring systems to ensure accurate data transmission and device integration.

  • What patient populations can be monitored with this device?

    The sensors are versatile and intended for use across a broad spectrum of patients, including neonatal, pediatric, and adult individuals, allowing for clinical flexibility.