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510(k) K911990

ECG FEMALE-TO-PIN SNAP ELECTRODE W/LEADS AND EXT. by Somnitec, Inc. — Product Code DRX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1991
Date Received
May 6, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Electrocardiograph
Device Class
Class II
Regulation Number
870.2360
Review Panel
CV
Submission Type

Other clearances by Somnitec, Inc.

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  • K912817 — SOMNIMIC (R) (July 26, 1991)
  • K912234 — SOMNIPROBE(R) MODEL NUMBER 10093, MODIFICATION (July 22, 1991)

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