The following data is part of a premarket notification filed by Medtech Intl., Inc. with the FDA for Iv Mate.
| Device ID | K853843 |
| 510k Number | K853843 |
| Device Name: | IV MATE |
| Classification | Monitor, Electric For Gravity Flow Infusion Systems |
| Applicant | MEDTECH INTL., INC. 949 SOUTH ORANGE BLOSSOM TRAIL Apopka, FL 32703 |
| Contact | Jonathan Rosen |
| Correspondent | Jonathan Rosen MEDTECH INTL., INC. 949 SOUTH ORANGE BLOSSOM TRAIL Apopka, FL 32703 |
| Product Code | FLN |
| CFR Regulation Number | 880.2420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-16 |
| Decision Date | 1986-01-09 |