510(k) K834475

RESPIRODYNE PULMONARY FUNCTION TEST by Chesebrough-Pond'S U.S.A. Co. — Product Code BZG

K834475 is an FDA 510(k) premarket notification submitted by Chesebrough-Pond'S U.S.A. Co. for the device "RESPIRODYNE PULMONARY FUNCTION TEST". The FDA issued a decision of Substantially Equivalent on February 17, 1984. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Chesebrough-Pond'S U.S.A. Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 1984
Date Received
December 20, 1983
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