INFANT OXYGEN TREATMENT HOOD


Device Classification Name

chamber, hyperbaric

510(k) Number K011565
Device Name INFANT OXYGEN TREATMENT HOOD
Original Applicant
GULF COAST HYPERBARICS, INC.
4309 green leaf circle
panama city, 
FL 
32404

Original Contact james w mccarthy
Regulation Number 868.5470
Classification Product Code
CBF  
Date Received 05/21/2001
Decision Date 08/16/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized