510(k) K973646

BIRD SENTRY BLENDER/ ANALYZER / BIRD SENTRY LOW FLOW BLENDER/ANALYZER by Bird Products Corp. — Product Code BZR

K973646 is an FDA 510(k) premarket notification submitted by Bird Products Corp. for the device "BIRD SENTRY BLENDER/ ANALYZER / BIRD SENTRY LOW FLOW BLENDER/ANALYZER". The FDA issued a decision of Substantially Equivalent on May 7, 1998. The device falls under product code BZR (Mixer, Breathing Gases, Anesthesia Inhalation), a Class II device regulated under 21 CFR 868.5330. Bird Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 1998
Date Received
September 24, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mixer, Breathing Gases, Anesthesia Inhalation
Device Class
Class II
Regulation Number
868.5330
Review Panel
AN
Submission Type