SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM
FDA premarket approval P080009/S012 · decided 2016-03-15
Approval details
- PMA number
- P080009
- Supplement
- S012
- 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
- 2015-12-17
- Decision date
- 2016-03-15
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- PDR
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Lubbock, TX
- Statement
- Approval for software changes to address previous software anomalies (modifications to the Bedside Monitoring Unit (BMU) software to address wireless driver-caused shutdowns, BMU software modifications to address noninvasive blood pressure (NIBP) measurements).
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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 |