The following data is part of a premarket notification filed by Carefusion with the FDA for Mz1000.
| Device ID | K132413 |
| 510k Number | K132413 |
| Device Name: | MZ1000 |
| Classification | Set, Administration, Intravascular |
| Applicant | CAREFUSION 10020 PACIFIC MESA BLVD San Diego, CA 92121 |
| Contact | Michelle J Badal, Rac |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-08-02 |
| Decision Date | 2013-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20885403230193 | K132413 | 000 |