FDA 510(k), K182868, INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor
FDA 510(k), K182868, INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor
Regular price
$149.00 USD
Regular price
Sale price
$149.00 USD
Unit price
/
per
510(K) Number: K182868
Device Name: INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor
Manufacturer: Samir Ibrahim
Device Classification Name: Oximeter, Tissue Saturation
Regulation Number: MUD
Classification Product Code: 10/12/2018
Date Received: 01/08/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor
Manufacturer: Samir Ibrahim
Device Classification Name: Oximeter, Tissue Saturation
Regulation Number: MUD
Classification Product Code: 10/12/2018
Date Received: 01/08/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
View full details