Aura SP104

• FDA 510(k) K172209 decided 18 May 2018 Active
• FDA GUDID UDI-DI 00860011785293 listed 25 Mar 2024 Listed

1. 18 May 2018 Cleared FDA 510(k) K172209
2. 25 Mar 2024 Listed FDA GUDID 00860011785293

Trade name

Aura

Generic name

Removable ambulatory appliance skin-adherent patch

Model / Ref / Catalog

SP104

Primary DI / UDI-DI

00860011785293

510(k) Number

K172209 ↗

FDA product code

GWM

GMDN term

Removable ambulatory appliance skin-adherent patch

Device class

Class II

Regulation number

882.1620

GUDID distribution status

In Commercial Distribution

Category: Removable ambulatory appliance skin-adherent patch

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• HICP200 Patient/Monitor Interconnect Cable by Innerspace Neuro Solutions, Inc.
• ICP-TEMP-Adapter 094323-001 by RAUMEDIC AG
• CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1 by INTEGRA NEUROSCIENCES
• INTEGRA CAMINO ICP MONITOR by Intrgra Lifesciences Corporation
• OPX-VX FEBEROPTIC INTRACRANIAL PRESSURE MONITORING CATHETER WITH DRAINAGE by Innerspace Medical, Inc.
• LICOX PMO BRAIN MONITORING SYSTEM by Integra Lifesciences Corporation

• Aura SP103

  Class II

  FDA 510(k) K172209 Active Cleared 18 May 2018 GUDID on market

• Aura TB101

  Class II

  FDA 510(k) K172209 Active Cleared 18 May 2018 GUDID on market

• Aura SP102

  Class II

  FDA 510(k) K172209 Active Cleared 18 May 2018 GUDID on market

• Aura SP101

  Class II

  FDA 510(k) K172209 Active Cleared 18 May 2018 GUDID on market

See all devices from Branchpoint & Aura Development LLC →