PRONEB ULTRA MODEL NUMBER 85B0100


information about

Device Classification Name

compressor, air, portable

510(k) Number K002862
Device Name PRONEB ULTRA MODEL NUMBER 85B0100
Original Applicant
PARI HOLDING CO.
13800 hull st. rd.
midlothian, 
VA 
23112

Original Contact debra a pekar
Regulation Number 868.6250
Classification Product Code
BTI  
Date Received 09/13/2000
Decision Date 03/13/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

Type Traditional
Reviewed by Third Party No

Combination Product

No