The following data is part of a premarket notification filed by Medix Medical Electronics (u.s.a.), Inc. with the FDA for Insulin Pump Insumat 229.
| Device ID | K853393 |
| 510k Number | K853393 |
| Device Name: | INSULIN PUMP INSUMAT 229 |
| Classification | Pump, Infusion |
| 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 | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-12 |
| Decision Date | 1985-11-18 |