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Somnitec, Inc.
FDA Regulatory Profile
Summary
Total Recalls
0
510(k) Clearances
4
Inspections
0
Compliance Actions
0
Recent 510(k) Clearances
K-Number
Device
Date
K911989
GOLD CUP EEG CUTANEOUS ELECTRODE W/LEAD AND EXT.
July 30, 1991
K912817
SOMNIMIC (R)
July 26, 1991
K912234
SOMNIPROBE(R) MODEL NUMBER 10093, MODIFICATION
July 22, 1991
K911990
ECG FEMALE-TO-PIN SNAP ELECTRODE W/LEADS AND EXT.
June 21, 1991