The following data is part of a premarket notification filed by Medfusion, Inc. with the FDA for Syringe Infusion Pump.
Device ID | K890120 |
510k Number | K890120 |
Device Name: | SYRINGE INFUSION PUMP |
Classification | Pump, Infusion |
Applicant | MEDFUSION, INC. 3070 BUSINESS PARK DR. Norcross, GA 30071 |
Contact | Ruffin Booth |
Correspondent | Ruffin Booth MEDFUSION, INC. 3070 BUSINESS PARK DR. Norcross, GA 30071 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-01-11 |
Decision Date | 1989-07-27 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00610586032595 | K890120 | 000 |