The following data is part of a premarket notification filed by Integrated Medical Systems, Inc. with the FDA for Life Support For Trauma And Trnsport (lstat) G6 Lite.
| Device ID | K082256 |
| 510k Number | K082256 |
| Device Name: | LIFE SUPPORT FOR TRAUMA AND TRNSPORT (LSTAT) G6 LITE |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | INTEGRATED MEDICAL SYSTEMS, INC. 1984 OBISPO AVE. Signal Hill, CA 90755 -1234 |
| Contact | Renate A Maclaren |
| Correspondent | Renate A Maclaren INTEGRATED MEDICAL SYSTEMS, INC. 1984 OBISPO AVE. Signal Hill, CA 90755 -1234 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-08 |
| Decision Date | 2008-09-26 |
| Summary: | summary |