510(k) K873610

PEDIATRIC BUBBLE TRAP CAT. NO. B-100 by American Omni Medical, Inc. — Product Code BSY

K873610 is an FDA 510(k) premarket notification submitted by American Omni Medical, Inc. for the device "PEDIATRIC BUBBLE TRAP CAT. NO. B-100". The FDA issued a decision of Substantially Equivalent on November 5, 1987. The device falls under product code BSY (Catheters, Suction, Tracheobronchial), a Class I device regulated under 21 CFR 868.6810. American Omni Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1987
Date Received
September 8, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheters, Suction, Tracheobronchial
Device Class
Class I
Regulation Number
868.6810
Review Panel
AN
Submission Type