The following data is part of a premarket notification filed by Caesarea Medical Electronics Ltd. with the FDA for Noa Iii Enteral Nutrition Pump.
Device ID | K040957 |
510k Number | K040957 |
Device Name: | NOA III ENTERAL NUTRITION PUMP |
Classification | Pump, Infusion, Enteral |
Applicant | CAESAREA MEDICAL ELECTRONICS LTD. 16 SHACHAM STREET INDUSTRIAL PARK Caesarea, IL 38900 |
Contact | Gali Tzury |
Correspondent | Gali Tzury CAESAREA MEDICAL ELECTRONICS LTD. 16 SHACHAM STREET INDUSTRIAL PARK Caesarea, IL 38900 |
Product Code | LZH |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-04-13 |
Decision Date | 2004-05-21 |