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510(k) K800596

VITA/TRAC 4-FUNCTION VITAL SIGN MONITOR by Bib, Inc. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1980
Date Received
March 17, 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)
  • K801389 — BARO/TRAC II & VITA/TRAC, VITAL SIGN MON (July 28, 1980)
  • K800782 — PACE-PULSE/COMPUTRAC (May 28, 1980)

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