The following data is part of a premarket notification filed by Narco Scientific with the FDA for As 700 Series Infusion Pump Admin..
Device ID | K821377 |
510k Number | K821377 |
Device Name: | AS 700 SERIES INFUSION PUMP ADMIN. |
Classification | Set, Administration, Intravascular |
Applicant | NARCO SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-05-10 |
Decision Date | 1982-07-02 |