510(k) K894906

ANESTHESIA BREATHING BAGS SIZES 1/2, 1,2,3 LITER by Med-Tek Corp. — Product Code BTC

K894906 is an FDA 510(k) premarket notification submitted by Med-Tek Corp. for the device "ANESTHESIA BREATHING BAGS SIZES 1/2, 1,2,3 LITER". The FDA issued a decision of Substantially Equivalent on September 18, 1989. The device falls under product code BTC (Bag, Reservoir), a Class I device regulated under 21 CFR 868.5320. Med-Tek Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 1989
Date Received
August 1, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bag, Reservoir
Device Class
Class I
Regulation Number
868.5320
Review Panel
AN
Submission Type