The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Ohmeda 9000 Syringe Pump.
Device ID | K896023 |
510k Number | K896023 |
Device Name: | OHMEDA 9000 SYRINGE PUMP |
Classification | Pump, Infusion |
Applicant | OHMEDA MEDICAL OHMEDA DRIVE, P.O. BOX 7550 Madison, WI 53707 -7550 |
Contact | Timothy M Davis |
Correspondent | Timothy M Davis OHMEDA MEDICAL OHMEDA DRIVE, P.O. BOX 7550 Madison, WI 53707 -7550 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-10-17 |
Decision Date | 1990-01-04 |