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Nonin LS1-9R

by Nonin Medical, Inc.

Nonin LS1-9R is a Class II device made by Nonin Medical, Inc., cleared under FDA 510(k) K063752 on 4 May 2007 and listed in FDA GUDID since 24 Aug 2016 (UDI-DI 00849686072181), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K063752

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00849686072181 UDI-DI Date24 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK063752 Date4 May 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K063752 decided 4 May 2007 Active
  • FDA GUDID UDI-DI 00849686072181 listed 24 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K063752
  2. Listed FDA GUDID 00849686072181

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Nonin
Generic name
Carbon dioxide monitor
Model / reference
LS1-9R
Primary DI / UDI-DI
00849686072181
510(k) Number
FDA product code
CCK, DQA
GMDN term
Carbon dioxide monitor
Device class
Class II
Regulation number
868.1400, 870.2700
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Pulse oximeterPulse oximeter, line-poweredCarbon dioxide monitor

Cleared under the same submission (K063752)

and 4 more cleared under K063752

Similar devices

Other devices filed under FDA product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase).

Other devices from Nonin Medical, Inc.

See all devices from Nonin Medical, Inc. →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)