510(k) K801756

MMI/GAELTEC CATHETER TIP TRANSDUC by Medical Measurements, Inc. — Product Code DXO

K801756 is an FDA 510(k) premarket notification submitted by Medical Measurements, Inc. for the device "MMI/GAELTEC CATHETER TIP TRANSDUC". The FDA issued a decision of Substantially Equivalent on August 20, 1980. The device falls under product code DXO (Transducer, Pressure, Catheter Tip), a Class II device regulated under 21 CFR 870.2870. Medical Measurements, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1980
Date Received
July 28, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Pressure, Catheter Tip
Device Class
Class II
Regulation Number
870.2870
Review Panel
CV
Submission Type