510(k) K921306

ARGIS PULMONARY FUNCTION TESTING SYSTEM by Med Science — Product Code BZC

K921306 is an FDA 510(k) premarket notification submitted by Med Science for the device "ARGIS PULMONARY FUNCTION TESTING SYSTEM". The FDA issued a decision of Substantially Equivalent on June 25, 1993. The device falls under product code BZC (Calculator, Pulmonary Function Data), a Class II device regulated under 21 CFR 868.1880. Med Science has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1993
Date Received
March 18, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator, Pulmonary Function Data
Device Class
Class II
Regulation Number
868.1880
Review Panel
AN
Submission Type