The following data is part of a premarket notification filed by Spectrum Medical, Llp with the FDA for M4 Monitor.
| Device ID | K110957 |
| 510k Number | K110957 |
| Device Name: | M4 MONITOR |
| Classification | Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
| Applicant | SPECTRUM MEDICAL, LLP CHELTENHAM ROAD EAST Gloucester, GB Gl2 9ql |
| Contact | Steve Turner |
| Product Code | DRY |
| CFR Regulation Number | 870.4330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-04-05 |
| Decision Date | 2011-05-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060434420206 | K110957 | 000 |
| 05060434420190 | K110957 | 000 |
| 05060434420183 | K110957 | 000 |
| 05060434420176 | K110957 | 000 |
| 05060434420169 | K110957 | 000 |
| 05060434420152 | K110957 | 000 |
| 05060434420046 | K110957 | 000 |