The following data is part of a premarket notification filed by Nobles-lai Engineering, Inc. with the FDA for Nobles-lai Engineering Infusion Pump.
Device ID | K895688 |
510k Number | K895688 |
Device Name: | NOBLES-LAI ENGINEERING INFUSION PUMP |
Classification | Withdrawal/infusion Pump |
Applicant | NOBLES-LAI ENGINEERING, INC. 3033 S. HARBOR BLVD. Santa Ana, CA 92704 |
Contact | Nobles, Ph.d |
Correspondent | Nobles, Ph.d NOBLES-LAI ENGINEERING, INC. 3033 S. HARBOR BLVD. Santa Ana, CA 92704 |
Product Code | DQI |
CFR Regulation Number | 870.1800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-09-22 |
Decision Date | 1990-02-26 |