The following data is part of a premarket notification filed by Carefusion 303, Inc. with the FDA for Alaris System With Guardrails Suite Mx.
| Device ID | K133532 |
| 510k Number | K133532 |
| Device Name: | ALARIS SYSTEM WITH GUARDRAILS SUITE MX |
| Classification | Pump, Infusion |
| Applicant | CAREFUSION 303, INC. 10020 PACIFIC MESA BLVD. San Diego, CA 92121 |
| Contact | Christine Caton |
| Correspondent | Christine Caton CAREFUSION 303, INC. 10020 PACIFIC MESA BLVD. San Diego, CA 92121 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-18 |
| Decision Date | 2014-08-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885403960116 | K133532 | 000 |
| 10885403897511 | K133532 | 000 |
| 10885403896118 | K133532 | 000 |
| 10885403960123 | K133532 | 000 |
| 10885403897535 | K133532 | 000 |
| 10885403896125 | K133532 | 000 |
| 10885403510489 | K133532 | 000 |
| 10885403510472 | K133532 | 000 |