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510(k) K880036

BIOMA 5000 by E.B.S., Inc. — Product Code DRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 1988
Date Received
January 5, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class
Class II
Regulation Number
870.2910
Review Panel
CV
Submission Type

Other clearances by E.B.S., Inc.

  • K872370 — BIOMA 3500 (December 7, 1987)
  • K862808 — BIOMA 2000 (February 19, 1987)

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