The following data is part of a premarket notification filed by Be Technologies, Inc. with the FDA for Uroflowmeter.
Device ID | K142425 |
510k Number | K142425 |
Device Name: | Uroflowmeter |
Classification | Uroflowmeter |
Applicant | BE TECHNOLOGIES, INC. 2939 20th Avenue San Francisco, CA 94132 |
Contact | Edward Belotserkovsky |
Correspondent | Angela Mallery NAMSA 4050 Olson Memorial Highway, Suite 450 Minneapolis, MN 55442 |
Product Code | EXY |
CFR Regulation Number | 876.1800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-08-29 |
Decision Date | 2014-10-27 |
Summary: | summary |