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Sensoronics SB-MALNC-9A

by Sensoronics Incorporated

Sensoronics SB-MALNC-9A is a Class II device made by Sensoronics Incorporated, cleared under FDA 510(k) K083010 on 10 Jun 2009 and listed in FDA GUDID since 26 Sep 2016 (UDI-DI 00851456007194), active as of 22 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 22 Oct 2026

Documents

510(k) K083010

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00851456007194 UDI-DI Date26 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK083010 Date10 Jun 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K083010 decided 10 Jun 2009 Active
  • FDA GUDID UDI-DI 00851456007194 listed 26 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K083010
  2. Listed FDA GUDID 00851456007194

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Sensoronics
Generic name
Pulse oximeter probe, reusable
Model / reference
SB-MALNC-9A
Primary DI / UDI-DI
00851456007194
510(k) Number
FDA product code
DQA
GMDN term
Pulse oximeter probe, reusable
Device class
Class II
Regulation number
870.2700
GUDID distribution status
In Commercial Distribution

Related devices

Category: Pulse oximeter probe, reusable

Cleared under the same submission (K083010)

and 8 more cleared under K083010

Similar devices

Other devices filed under FDA product code DQA (Oximeter).

Other devices from Sensoronics Incorporated

See all devices from Sensoronics Incorporated →

Properties

  • Contains latex
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)