LOW FLUID ALARM


Device Classification Name

monitor, electric for gravity flow infusion systems

510(k) Number K080704
Device Name LOW FLUID ALARM
Applicant
EM-TEC GMBH
lerchenberg 20
finning, bavaria, 

DE

86923

Applicant Contact bernhard brand
Regulation Number 880.2420
Classification Product Code
FLN  
Date Received 03/12/2008
Decision Date 04/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Abbreviated
Reviewed by Third Party Yes

Combination Product

No