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510(k) K830916

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

K830916 is an FDA 510(k) premarket notification submitted by Bib, Inc. for the device "VITA/TRAC 4 FUNCTION VITAL SIGN MONITOR". The FDA issued a decision of Substantially Equivalent on July 7, 1983. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Bib, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 1983
Date Received
March 22, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

Other clearances by Bib, Inc.

  • 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)
  • K800782 — PACE-PULSE/COMPUTRAC (May 28, 1980)

Other clearances for product code DRT

  • K261286 — The Circadia C300 System (C300) (May 20, 2026)
  • K252676 — The Circadia C300 System (C300) (February 3, 2026)
  • K253388 — Sleepiz One+ (Model 2.5) (January 28, 2026)
  • K251364 — Sleepiz One+ (2.5) (July 29, 2025)
  • K234003 — The Circadia C200 System (May 30, 2024)
  • K232354 — Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central (March 22, 2024)
  • K231733 — Neteera 130H-Plus Vital Sign Monitoring Sensor (February 9, 2024)
  • K223163 — Sleepiz One+ (August 18, 2023)
  • K212143 — Neteera 130H/131H Vital Sign Monitoring Sensor (September 28, 2022)
  • K202138 — Cardiac Trigger Monitor (May 14, 2021)

FDA data resources