PMA P080009S011
- Device
- SEDASYS COMPUTER- ASSISTED PERSONALIZED SEDATION SYSTEM
- Applicant
- Scott Laboratories, Inc.
- PMA number
- P080009
- Supplement
- S011
- Product code
- PDR
- Decision date
- 2016-02-12
- Classification
- Computer-assisted Personalized Sedation System
- Generic name
- Computer-assisted personalized sedation system
- Approval order statement
- Approval for software changes to pulse oximeter artifact mitigation period, redundant pulse oximetry signal quality advisory, allotted time for pulse oximeter synchronization (reset and return to normal operation), and the ability to select Clinician Response (manual) mode after starting treatment using automated response mode.
Current openFDA PMA Record#
- Device
- SEDASYS COMPUTER- ASSISTED PERSONALIZED SEDATION SYSTEM
- Applicant
- Scott Laboratories, Inc.
- PMA number
- P080009
- Supplement
- S011
- Product code
- PDR
- Generic name
- Computer-assisted personalized sedation system
- Decision date
- 2016-02-12
- Decision code
- APPR
- Date received
- 2015-11-18
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for software changes to pulse oximeter artifact mitigation period, redundant pulse oximetry signal quality advisory, allotted time for pulse oximeter synchronization (reset and return to normal operation), and the ability to select Clinician Response (manual) mode after starting treatment using automated response mode.