MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR


Device Classification Name

ventilator, emergency, powered (resuscitator)

510(k) Number K991785
Device Name MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR
Applicant
INSTRUMENTATION INDUSTRIES, INC.
2990 industrial blvd.
bethel park, 
PA 
15102

Applicant Contact tricia wood
Correspondent
INSTRUMENTATION INDUSTRIES, INC.
2990 industrial blvd.
bethel park, 
PA 
15102

Correspodent Contact tricia wood
Regulation Number 868.5925
Classification Product Code
BTL  
Date Received 05/25/1999
Decision Date 08/17/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls
Category: Uncategorized