510(k) K873695

MODEL 1859 TUMI/PRESSURE MODULE by Life-Tech Intl., Inc. — Product Code EXY

K873695 is an FDA 510(k) premarket notification submitted by Life-Tech Intl., Inc. for the device "MODEL 1859 TUMI/PRESSURE MODULE". The FDA issued a decision of Substantially Equivalent on January 27, 1988. The device falls under product code EXY (Uroflowmeter), a Class II device regulated under 21 CFR 876.1800. Life-Tech Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1988
Date Received
September 14, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Uroflowmeter
Device Class
Class II
Regulation Number
876.1800
Review Panel
GU
Submission Type