The following data is part of a premarket notification filed by Spectrum Medical Ltd with the FDA for M3 Monitor.
| Device ID | K091908 |
| 510k Number | K091908 |
| Device Name: | M3 MONITOR |
| Classification | Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
| Applicant | SPECTRUM MEDICAL LTD HARRIER 4,METEOR BUSINESS PARK CHELTENHAM ROAD EAST Gloucester, Gloucesterhsire, GB Gl2 9ql |
| Contact | Steve Turner |
| Correspondent | Jeff D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | DRY |
| CFR Regulation Number | 870.4330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-06-25 |
| Decision Date | 2009-07-10 |
| Summary: | summary |