AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2


Device Classification Name

plethysmograph, impedance

510(k) Number K081035
Device Name AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2
Applicant
OSYPKA MEDICAL, INC.
7855 ivanhoe ave., suite 226
la jolla, 
CA 
92037

Applicant Contact markus osypka
Correspondent
OSYPKA MEDICAL, INC.
7855 ivanhoe ave., suite 226
la jolla, 
CA 
92037

Correspodent Contact markus osypka
Regulation Number 870.2770
Classification Product Code
DSB  
Date Received 04/11/2008
Decision Date 05/30/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No