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510(k) K800782

PACE-PULSE/COMPUTRAC by Bib, Inc. — Product Code KRE

K800782 is an FDA 510(k) premarket notification submitted by Bib, Inc. for the device "PACE-PULSE/COMPUTRAC". The FDA issued a decision of Substantially Equivalent on May 28, 1980. The device falls under product code KRE (Analyzer, Pacemaker Generator Function, Indirect), a Class II device regulated under 21 CFR 870.3640. Bib, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1980
Date Received
April 8, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Pacemaker Generator Function, Indirect
Device Class
Class II
Regulation Number
870.3640
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)
  • K800596 — VITA/TRAC 4-FUNCTION VITAL SIGN MONITOR (July 21, 1980)

Other clearances for product code KRE

  • K110693 — PACEART OPTIMA SYSTEM SOFTWARE (June 8, 2011)
  • K072950 — CYGNUS 12 LEAD ECG MODULE (August 22, 2008)
  • K032926 — EKG SPEAKS (October 15, 2003)
  • K922742 — HPM 40 HEART PACEMAKER MONITOR (March 18, 1993)
  • K915632 — PACEART CPTS-86/12 (April 14, 1992)
  • K895535 — PACEVIEW (March 19, 1990)
  • K870909 — PACEMAKER FUNCTION ANALYZER (April 27, 1987)
  • K833647 — PACEMAKER SYS ANALYZER #384 (December 16, 1983)
  • K832959 — PACEMAKER SYS. ANALYZER 378 (November 14, 1983)
  • K803286 — CARDIOMEMO (March 17, 1981)

FDA data resources