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510(k) K900451

VITALMAX 800 NON-INVASIVE VITAL SIGN MONITOR/PULSE by Pace Tech, Inc. — Product Code DRT

K900451 is an FDA 510(k) premarket notification submitted by Pace Tech, Inc. for the device "VITALMAX 800 NON-INVASIVE VITAL SIGN MONITOR/PULSE". The FDA issued a decision of Substantially Equivalent on July 18, 1990. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Pace Tech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1990
Date Received
January 30, 1990
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 Pace Tech, Inc.

  • K951226 — VITALMAX 4000/MINIPACK 3100/3000 (November 21, 1996)
  • K953795 — VITALMAX 4100 (July 1, 1996)
  • K944541 — HANDYPACK 911SC (February 22, 1995)
  • K945385 — VITALMAX 800 PLUS/VITALMAX 810 PLUS/MINIPACK 300 (January 31, 1995)
  • K925701 — MINIPACK 911-STC (August 11, 1994)
  • K934385 — MINIPACK 3100/3000 MODIFICATION (August 10, 1994)
  • K933624 — VITALMAX 4000 (July 19, 1994)
  • K930559 — VITALMAX 800-C (September 3, 1993)
  • K912835 — MINI-PACK 911 SERIES (February 3, 1992)
  • K912880 — VITALMAX 510/520 (November 14, 1991)

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