The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Data Port Pc, Model 12181.
Device ID | K040114 |
510k Number | K040114 |
Device Name: | ABBOTT DATA PORT PC, MODEL 12181 |
Classification | Pump, Infusion |
Applicant | ABBOTT LABORATORIES D-389, BLDG. J45-2 200 ABBOTT PARK ROAD Abbott Park, IL 60064 -6157 |
Contact | Patricia Melerski |
Correspondent | Patricia Melerski ABBOTT LABORATORIES D-389, BLDG. J45-2 200 ABBOTT PARK ROAD Abbott Park, IL 60064 -6157 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-01-20 |
Decision Date | 2004-01-29 |
Summary: | summary |