510(k) K913110

PDM-1 DEVICE:CAPD DISINFECTING DEVICE, MODIFIED by Microwave Medical Systems, Inc. — Product Code DRQ

K913110 is an FDA 510(k) premarket notification submitted by Microwave Medical Systems, Inc. for the device "PDM-1 DEVICE:CAPD DISINFECTING DEVICE, MODIFIED". The FDA issued a decision of Substantially Equivalent on October 10, 1991. The device falls under product code DRQ (Amplifier And Signal Conditioner, Transducer Signal), a Class II device regulated under 21 CFR 870.2060. Microwave Medical Systems, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1991
Date Received
July 12, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amplifier And Signal Conditioner, Transducer Signal
Device Class
Class II
Regulation Number
870.2060
Review Panel
CV
Submission Type