ACAPELLA


codes

Device Classification Name

spirometer, therapeutic (incentive)

510(k) Number K002768
Device Name ACAPELLA
Original Applicant
DHD HEALTHCARE CORP.
one madison st.
wampsville, 
NY 
13163

Original Contact lawrence weinstein
Regulation Number 868.5690
Classification Product Code
BWF  
Date Received 09/06/2000
Decision Date 12/05/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

Type Traditional
Reviewed by Third Party No

Combination Product

No