510(k) K790754

BROWNE MODEL CF-1 AND CF-1G by Browne Corp. — Product Code FAP

K790754 is an FDA 510(k) premarket notification submitted by Browne Corp. for the device "BROWNE MODEL CF-1 AND CF-1G". The FDA issued a decision of Substantially Equivalent on Jun 1, 1979. The device falls under product code FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device), a Class II device regulated under 21 CFR 876.1620. Browne Corp. has 6 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 1, 1979
Date Received
Apr 17, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
Device Class
Class II
Regulation Number
876.1620
Review Panel
GU
Submission Type
510(k) Exempt

Source: FDA 510(k) database entry for K790754. Report a data issue: hello@regdatalab.com.