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510(k) K102174

ZOLL PROPAQ M by Zoll Medical Corporation, World Wide Headquarters — Product Code DRT

K102174 is an FDA 510(k) premarket notification submitted by Zoll Medical Corporation, World Wide Headquarters for the device "ZOLL PROPAQ M". The FDA issued a decision of Substantially Equivalent on September 15, 2010. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Zoll Medical Corporation, World Wide Headquarters has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2010
Date Received
August 2, 2010
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 Zoll Medical Corporation, World Wide Headquarters

  • K133239 — ZOLL E SERIES (January 16, 2015)
  • K133269 — ZOLL X SERIES (May 22, 2014)
  • K120406 — ZOLL FULLY AUTOMATIC AED PLUS (October 26, 2012)
  • K120907 — ZOLL R SERIES (September 25, 2012)
  • K112761 — ZOLL PROPAQ MD (April 25, 2012)
  • K112432 — ZOLL X SERIES (March 21, 2012)
  • K111296 — ZOLL RESCUENETLINK (October 27, 2011)
  • K111594 — ZOLL E SERIES (August 17, 2011)
  • K110361 — ZOLL R SERIES WITH 2010 AHA GUIDELINES SOFTWARE UPDATE (March 8, 2011)
  • K110154 — ZOLL AED PLUS WITH 2010 AHA GUIDLINES SOFTWARE UPDATE (February 17, 2011)

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