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Nellcor SC-PR

by Covidien LP

Nellcor SC-PR is a Class II device made by Covidien LP, cleared under FDA 510(k) K030930 on 23 May 2003 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 10884522042550), 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) K030930

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 Number10884522042550 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK030930 Date23 May 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K030930 decided 23 May 2003 Active
  • FDA GUDID UDI-DI 10884522042550 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K030930
  2. Listed FDA GUDID 10884522042550

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Nellcor
Generic name
Pulse oximeter probe, single-use
Model / reference
SC-PR
Primary DI / UDI-DI
10884522042550
510(k) Number
FDA product code
DQA
GMDN term
Pulse oximeter probe, single-use
Device class
Class II
Regulation number
870.2700
GUDID distribution status
In Commercial Distribution

Related devices

Category: Pulse oximeter probe, single-use

Cleared under the same submission (K030930)

and 1 more cleared under K030930

Similar devices in this category

Other devices filed under Pulse oximeter probe, single-use.

Other devices from Covidien LP

  • LigaSure MRASILF19

    Class II

  • Shiley 110860

    Class II

  • Shiley 110865

    Class II

  • Shiley 110870

    Class II

See all devices from Covidien LP →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)