The following data is part of a premarket notification filed by Strato Medical Corp. with the FDA for Stratofuse Syringe Piggyback Pump 1030.
| Device ID | K850488 |
| 510k Number | K850488 |
| Device Name: | STRATOFUSE SYRINGE PIGGYBACK PUMP 1030 |
| Classification | Pump, Infusion |
| Applicant | STRATO MEDICAL CORP. 123 BRIMBAL AVE. P.O.B.3148 Beverly, MA 01915 |
| Contact | Robert L Miller |
| Correspondent | Robert L Miller STRATO MEDICAL CORP. 123 BRIMBAL AVE. P.O.B.3148 Beverly, MA 01915 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-07 |
| Decision Date | 1985-03-21 |