LOTUS PULMONARY FUNCTION FILTER, MODELS CPF 101, CPF 102, CPF 103

Device Classification Name

spirometer, diagnostic

510(k) Number K033518
Device Name LOTUS PULMONARY FUNCTION FILTER, MODELS CPF 101, CPF 102, CPF 103
Applicant
CUSTOM PLASTIC PRODUCTS
28481 la falda
laguna niguel, 
CA 
92677

Applicant Contact jim barley
Correspondent
CUSTOM PLASTIC PRODUCTS
28481 la falda
laguna niguel, 
CA 
92677

Correspodent Contact jim barley
Regulation Number 868.1840
Classification Product Code
BZG  
Date Received 11/07/2003
Decision Date 03/10/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No