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510(k) K801389

BARO/TRAC II & VITA/TRAC, VITAL SIGN MON by Bib, Inc. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1980
Date Received
June 13, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
Submission Type

Other clearances by Bib, Inc.

  • K830916 — VITA/TRAC 4 FUNCTION VITAL SIGN MONITOR (July 7, 1983)
  • K801366 — DISPOSABLE TEMPERATURE PROBE COVER (July 28, 1980)
  • K800596 — VITA/TRAC 4-FUNCTION VITAL SIGN MONITOR (July 21, 1980)
  • K800782 — PACE-PULSE/COMPUTRAC (May 28, 1980)

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