510(k) K852307

PULMONARY TEST SYSTEM FUDAC-30 by Futuremed Div. of Future Impex Corp. — Product Code BZG

K852307 is an FDA 510(k) premarket notification submitted by Futuremed Div. of Future Impex Corp. for the device "PULMONARY TEST SYSTEM FUDAC-30". The FDA issued a decision of Substantially Equivalent on July 5, 1985. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Futuremed Div. of Future Impex Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 1985
Date Received
May 29, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Diagnostic
Device Class
Class II
Regulation Number
868.1840
Review Panel
AN
Submission Type