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 |