The following data is part of a premarket notification filed by Smith Assoc. with the FDA for Msi Pressure Infusor.
| Device ID | K973843 |
| 510k Number | K973843 |
| Device Name: | MSI PRESSURE INFUSOR |
| Classification | Infusor, Pressure, For I.v. Bags |
| Applicant | SMITH ASSOC. P.O. BOX 4341 Crofton, MD 21114 -4341 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith SMITH ASSOC. P.O. BOX 4341 Crofton, MD 21114 -4341 |
| Product Code | KZD |
| CFR Regulation Number | 880.5420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-08 |
| Decision Date | 1997-10-29 |