EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400


codes

Device Classification Name

set, i.v. fluid transfer

510(k) Number K002705
Device Name EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400
Original Applicant
BAXA CORP.
13760 east arapahoe rd.
englewood, 
CO 
80112 -3903

Original Contact carl steineck
Regulation Number 880.5440
Classification Product Code
LHI  
Subsequent Product Code
NEP  
Date Received 08/30/2000
Decision Date 03/28/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls