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Nonin 9847

by Nonin Medical, Inc.

Nonin 9847 is a Class II device made by Nonin Medical, Inc., cleared under FDA 510(k) K982969 on 12 Aug 1999 and listed in FDA GUDID since 24 Aug 2016 (UDI-DI 00849686074291), 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) K982969

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 Number00849686074291 UDI-DI Date24 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK982969 Date12 Aug 1999DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K982969 decided 12 Aug 1999 Active
  • FDA GUDID UDI-DI 00849686074291 listed 24 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K982969
  2. Listed FDA GUDID 00849686074291

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  • Withdrawn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
Pulse oximeter
Model / reference
9847
Primary DI / UDI-DI
00849686074291
510(k) Number
FDA product code
DQA
GMDN term
Pulse oximeter
Device class
Class II
Regulation number
870.2700
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Pulse oximeter

Cleared under the same submission (K982969)

Similar devices in this category

Other devices filed under Pulse oximeter.

Other devices from Nonin Medical, Inc.

See all devices from Nonin Medical, Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)