510(k) K924875

MICROTRAPPER/MICRODIGITRAPPER, ADD MODIFICATIONS by Synectics-Dantec — Product Code BZQ

K924875 is an FDA 510(k) premarket notification submitted by Synectics-Dantec for the device "MICROTRAPPER/MICRODIGITRAPPER, ADD MODIFICATIONS". The FDA issued a decision of ST on June 30, 1994. The device falls under product code BZQ (Monitor, Breathing Frequency), a Class II device regulated under 21 CFR 868.2375. Synectics-Dantec has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
ST ()
Decision Date
June 30, 1994
Date Received
September 14, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Breathing Frequency
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
Submission Type