The following data is part of a premarket notification filed by Sierra Biosearch Inc with the FDA for Mt Alert Infusion Monitor.
| Device ID | K013121 |
| 510k Number | K013121 |
| Device Name: | MT ALERT INFUSION MONITOR |
| Classification | Monitor, Electric For Gravity Flow Infusion Systems |
| Applicant | SIERRA BIOSEARCH INC 395 MT. TOM RD. Bishop, CA 93514 |
| Contact | Richard Citrenaum |
| Correspondent | Richard Citrenaum SIERRA BIOSEARCH INC 395 MT. TOM RD. Bishop, CA 93514 |
| Product Code | FLN |
| CFR Regulation Number | 880.2420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-18 |
| Decision Date | 2001-10-15 |
| Summary: | summary |