SEDASYS COMPUTER- ASSISTED PERSONALIZED SEDATION SYSTEM
FDA premarket approval P080009/S011 · decided 2016-02-12
Approval details
- PMA number
- P080009
- Supplement
- S011
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SEDASYS COMPUTER- ASSISTED PERSONALIZED SEDATION SYSTEM
- Generic name
- Computer-assisted personalized sedation system
- Applicant
- Scott Laboratories, Inc.
- Date received
- 2015-11-18
- Decision date
- 2016-02-12
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- PDR
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Lubbock, TX
- 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.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| B. CAT CONFIRM (K880694) | Scott Laboratories, Inc. | 1988-06-16 |
| MUG-INDOLE DISC (K874933) | Scott Laboratories, Inc. | 1988-01-05 |
| MYCO-FLUOR REAGENT A & B (K874662) | Scott Laboratories, Inc. | 1987-11-25 |
| IDENTICULT-BL (K873509) | Scott Laboratories, Inc. | 1987-10-15 |
| ANABAG (K871238) | Scott Laboratories, Inc. | 1987-04-03 |
| SERO-STAT R II STAPHYLOCOCCUS TEST (K863025) | Scott Laboratories, Inc. | 1986-09-15 |
| SELECTICULT-CHLAMYDIA (K852869) | Scott Laboratories, Inc. | 1985-09-19 |
| IDENTICULT-NEISSERIA (K852832) | Scott Laboratories, Inc. | 1985-07-19 |