The following data is part of a premarket notification filed by Draeger Medical Systems, Inc. with the FDA for Infinity Acute Care System, Infinity Mcable- Masimo Rainbow Set.
| Device ID | K113798 |
| 510k Number | K113798 |
| Device Name: | INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | Draeger Medical Systems, Inc. 6 TECH DRIVE Andover, MA 01810 |
| Contact | Beth A Zis |
| Correspondent | Beth A Zis Draeger Medical Systems, Inc. 6 TECH DRIVE Andover, MA 01810 |
| Product Code | MHX |
| Subsequent Product Code | BZQ |
| Subsequent Product Code | CCK |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DSK |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| Subsequent Product Code | FLS |
| Subsequent Product Code | MLD |
| Subsequent Product Code | MSX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-23 |
| Decision Date | 2012-03-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049098058100 | K113798 | 000 |
| 04049098003131 | K113798 | 000 |
| 04049098003667 | K113798 | 000 |
| 04049098009744 | K113798 | 000 |
| 04049098009751 | K113798 | 000 |
| 04049098009799 | K113798 | 000 |
| 04049098048484 | K113798 | 000 |
| 04049098048934 | K113798 | 000 |
| 04049098049665 | K113798 | 000 |
| 04049098049672 | K113798 | 000 |
| 04049098054409 | K113798 | 000 |
| 04049098054416 | K113798 | 000 |
| 04049098054423 | K113798 | 000 |
| 04049098054430 | K113798 | 000 |
| 04049098054454 | K113798 | 000 |
| 04049098003124 | K113798 | 000 |