The following data is part of a premarket notification filed by Medix Medical Electronics (u.s.a.), Inc. with the FDA for Infusafe 205 Catolog No. 205.000.
| Device ID | K852433 |
| 510k Number | K852433 |
| Device Name: | INFUSAFE 205 CATOLOG NO. 205.000 |
| Classification | Monitor, Electric For Gravity Flow Infusion Systems |
| Applicant | MEDIX MEDICAL ELECTRONICS (U.S.A.), INC. C/O WEINBERG-DORON & COMPANY 750 THIRD AVENUE New York, NY 10017 |
| Contact | Co. |
| Correspondent | Co. MEDIX MEDICAL ELECTRONICS (U.S.A.), INC. C/O WEINBERG-DORON & COMPANY 750 THIRD AVENUE New York, NY 10017 |
| Product Code | FLN |
| CFR Regulation Number | 880.2420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-10 |
| Decision Date | 1985-06-27 |