The following data is part of a premarket notification filed by Cardinal Health 303, Inc. with the FDA for Alaris System With Mms, Model 8xxx.
| Device ID | K072105 |
| 510k Number | K072105 |
| Device Name: | ALARIS SYSTEM WITH MMS, MODEL 8XXX |
| Classification | Pump, Infusion |
| Applicant | CARDINAL HEALTH 303, INC. 10221 WATERIDGE CIR. San Diego, CA 92121 |
| Contact | Stacy L Lewis |
| Correspondent | Stacy L Lewis CARDINAL HEALTH 303, INC. 10221 WATERIDGE CIR. San Diego, CA 92121 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-31 |
| Decision Date | 2007-12-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885403960109 | K072105 | 000 |
| 10885403515231 | K072105 | 000 |
| 10885403515323 | K072105 | 000 |
| 10885403830013 | K072105 | 000 |
| 10885403801532 | K072105 | 000 |
| 10885403810039 | K072105 | 000 |
| 10885403811036 | K072105 | 000 |
| 10885403812026 | K072105 | 000 |
| 10885403801549 | K072105 | 000 |
| 10885403810046 | K072105 | 000 |
| 10885403811043 | K072105 | 000 |
| 10885403812033 | K072105 | 000 |
| 10885403830020 | K072105 | 000 |
| 10885403896101 | K072105 | 000 |
| 10885403897504 | K072105 | 000 |
| 10885403515316 | K072105 | 000 |