Skip to content

Lifesense, Model LS1-9R

by Nonin Medical, Inc.

510(k) K063752

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 · Traditional NumberK063752 Date4 May 2007ClearedStatusActive

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  • Withdrawn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, 23 Sep 2026

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

The LIFESENSE, MODEL LS1-9R is a cardiovascular device that is substantially equivalent to a predicate device, as determined by FDA 510(k) clearance. It is classified under product code DQA and was reviewed by the Cardiovascular advisory committee.

The device was manufactured by Nonin Medical, Inc. in Plymouth, Minnesota, and received FDA clearance on May 4, 2007, under traditional 510(k) pathway K063752. It is supplied as a finished device for use in clinical settings, with no indication of sterility, single-use status, MRI safety, sizes, or storage conditions provided in the data.

Other devices from Nonin Medical, Inc.

See all devices from Nonin Medical, Inc. →

Questions

AI-generated answers, 23 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 LIFESENSE MODEL LS1-9R used for?

    The LIFESENSE MODEL LS1-9R is a cardiovascular device, as indicated by its product code DQA and review by the Cardiovascular advisory committee, intended for use in clinical settings based on its substantial equivalence to a predicate device.

  • How is the LIFESENSE MODEL LS1-9R supplied and is it sterile or single-use?

    The device is supplied as a finished device for use in clinical settings, but the provided data does not specify whether it is sterile, single-use, or reusable, so no indication of sterility or single-use status can be confirmed from the information given.

  • What sizes, models, or storage conditions apply to the LIFESENSE MODEL LS1-9R?

    The device data does not provide any information about sizes, additional models, or storage conditions for the LIFESENSE MODEL LS1-9R, so these details are not available from the authorization record.