ROADRUNNER, PEP THERAPY DEVICE


Device Classification Name

spirometer, therapeutic (incentive)

510(k) Number K991561
Device Name ROADRUNNER, PEP THERAPY DEVICE
Applicant
DHD HEALTHCARE CORP.
one madison st.
wampsville, 
NY 
13163

Applicant Contact larry weinstein
Correspondent
DHD HEALTHCARE CORP.
one madison st.
wampsville, 
NY 
13163

Correspodent Contact larry weinstein
Regulation Number 868.5690
Classification Product Code
BWF  
Date Received 05/04/1999
Decision Date 11/10/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No