510(k) K852515

ACCESSORY VENTILLARY(BREATHING) FREQUENCY MONITOR by Alternative Design Systems, Inc. — Product Code BZQ

K852515 is an FDA 510(k) premarket notification submitted by Alternative Design Systems, Inc. for the device "ACCESSORY VENTILLARY(BREATHING) FREQUENCY MONITOR". The FDA issued a decision of Substantially Equivalent on June 24, 1985. The device falls under product code BZQ (Monitor, Breathing Frequency), a Class II device regulated under 21 CFR 868.2375. Alternative Design Systems, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1985
Date Received
June 13, 1985
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