The following data is part of a premarket notification filed by The Master Medical Corp. with the FDA for Stat 2 Iv Pumpette.
| Device ID | K905498 |
| 510k Number | K905498 |
| Device Name: | STAT 2 IV PUMPETTE |
| Classification | Controller, Infusion, Intravascular, Electronic |
| Applicant | THE MASTER MEDICAL CORP. 201 SPEAR ST. SUITE 1111 San Francisco, CA 94105 |
| Contact | Charles L Morin |
| Correspondent | Charles L Morin THE MASTER MEDICAL CORP. 201 SPEAR ST. SUITE 1111 San Francisco, CA 94105 |
| Product Code | LDR |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-07 |
| Decision Date | 1991-04-16 |