Product code PDR
- Device name
- Computer-Assisted Personalized Sedation System
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Computer assisted system to administer a drug and control depth of sedation and provide monitoring and alarms for physiological vital signs and other parameters of sedation.
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P080009S012 | SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM | Scott Laboratories, Inc. | 2016-03-15 |
| P080009S011 | SEDASYS COMPUTER- ASSISTED PERSONALIZED SEDATION SYSTEM | Scott Laboratories, Inc. | 2016-02-12 |
| P080009S010 | SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM | Scott Laboratories, Inc. | 2016-01-26 |
| P080009S009 | SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM | Scott Laboratories, Inc. | 2015-10-08 |
| P080009S007 | SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM | Scott Laboratories, Inc. | 2015-10-06 |
| P080009S008 | SEDASYS COMPUTER ASSISTED PERSONALIZED SEDATION SYSTEM | Scott Laboratories, Inc. | 2015-07-16 |
| P080009S005 | SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM | Scott Laboratories, Inc. | 2015-03-25 |
| P080009S004 | SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEMS | Scott Laboratories, Inc. | 2015-03-23 |
| P080009S003 | SEDASYS COMPUTER ASSISTED PERSONALIZED SEDATION SYSTEM | Scott Laboratories, Inc. | 2014-11-03 |
| P080009S002 | SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM | Scott Laboratories, Inc. | 2014-10-07 |
| P080009S001 | SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM | Scott Laboratories, Inc. | 2014-06-16 |
| P080009 | SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM | Scott Laboratories, Inc. | 2013-05-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 20705036003615 | SEDASYS | ETHICON ENDO-SURGERY, INC. | 2016-07-15 |
| 30705036003599 | SEDASYS | ETHICON ENDO-SURGERY, INC. | 2016-07-15 |
| 30705036003582 | SEDASYS | ETHICON ENDO-SURGERY, INC. | 2016-07-15 |
| 30705036003575 | SEDASYS | ETHICON ENDO-SURGERY, INC. | 2016-07-15 |
| 30705036003605 | SEDASYS | ETHICON ENDO-SURGERY, INC. | 2016-07-15 |
| 30705036003612 | SEDASYS | ETHICON ENDO-SURGERY, INC. | 2016-07-15 |
| 20705036003813 | SEDASYS | ETHICON ENDO-SURGERY, INC. | 2016-07-15 |
| 20705036003806 | SEDASYS | ETHICON ENDO-SURGERY, INC. | 2016-07-15 |
| 20705036003783 | SEDASYS | ETHICON ENDO-SURGERY, INC. | 2016-07-15 |
| 20705036003776 | SEDASYS | ETHICON ENDO-SURGERY, INC. | 2016-07-15 |
| 20705036003608 | SEDASYS | ETHICON ENDO-SURGERY, INC. | 2016-07-15 |
| 20705036003592 | SEDASYS | ETHICON ENDO-SURGERY, INC. | 2016-07-15 |
| 20705036003585 | SEDASYS | ETHICON ENDO-SURGERY, INC. | 2016-07-15 |
| 20705036003578 | SEDASYS | ETHICON ENDO-SURGERY, INC. | 2016-07-15 |
| 30705036003773 | SEDASYS | ETHICON ENDO-SURGERY, INC. | 2016-07-15 |
| 30705036003780 | SEDASYS | ETHICON ENDO-SURGERY, INC. | 2016-07-15 |
| 30705036003803 | SEDASYS | ETHICON ENDO-SURGERY, INC. | 2016-07-15 |
| 30705036003810 | SEDASYS | ETHICON ENDO-SURGERY, INC. | 2016-07-15 |
| 20705036010224 | SEDASYS | ETHICON ENDO-SURGERY, INC. | 2014-09-17 |
| 10705036003434 | SEDASYS | ETHICON ENDO-SURGERY, INC. | 2014-09-17 |
| 30705036003568 | SEDASYS | ETHICON ENDO-SURGERY, INC. | 2014-09-17 |
| 30705036003551 | SEDASYS | ETHICON ENDO-SURGERY, INC. | 2014-09-17 |
| 20705036003561 | SEDASYS | ETHICON ENDO-SURGERY, INC. | 2014-09-17 |
| 20705036003554 | SEDASYS | ETHICON ENDO-SURGERY, INC. | 2014-09-17 |
| 10705036010210 | SEDASYS | ETHICON ENDO-SURGERY, INC. | 2014-09-17 |
| 10705036010203 | SEDASYS | ETHICON ENDO-SURGERY, INC. | 2014-09-17 |
| 10705036010180 | SEDASYS | ETHICON ENDO-SURGERY, INC. | 2014-09-17 |