The following data is part of a premarket notification filed by Laborie Medical Technologies, Ltd. with the FDA for Infusion Pump, Model No. Udp-5.
Device ID | K942023 |
510k Number | K942023 |
Device Name: | INFUSION PUMP, MODEL NO. UDP-5 |
Classification | Device, Cystometric, Hydraulic |
Applicant | LABORIE MEDICAL TECHNOLOGIES, LTD. 7 GREEN TREE DR. #4 South Burlington, VT 05403 |
Contact | Fred Buffa |
Correspondent | Fred Buffa LABORIE MEDICAL TECHNOLOGIES, LTD. 7 GREEN TREE DR. #4 South Burlington, VT 05403 |
Product Code | FEN |
CFR Regulation Number | 876.1620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-04-26 |
Decision Date | 1994-07-12 |