MODEL 120, OXYSOFT, INFRARED DATA CONVERTER, MODEL 120


the company

Device Classification Name

oximeter

510(k) Number K002787
Device Name MODEL 120, OXYSOFT, INFRARED DATA CONVERTER, MODEL 120
Original Applicant
PALCO LABS, INC.
8030 soquel ave.
santa cruz, 
CA 
95062

Original Contact richella goo
Regulation Number 870.2700
Classification Product Code
DQA  
Date Received 09/07/2000
Decision Date 11/29/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Anesthesiology

Type Special
Reviewed by Third Party No

Combination Product

No