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510(k) K050853

PMP4 SPIROPRO by Card Guard Scientific Survival , Ltd. — Product Code BZH

K050853 is an FDA 510(k) premarket notification submitted by Card Guard Scientific Survival , Ltd. for the device "PMP4 SPIROPRO". The FDA issued a decision of Substantially Equivalent on May 4, 2005. The device falls under product code BZH (Meter, Peak Flow, Spirometry), a Class II device regulated under 21 CFR 868.1860. Card Guard Scientific Survival , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2005
Date Received
April 4, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Meter, Peak Flow, Spirometry
Device Class
Class II
Regulation Number
868.1860
Review Panel
AN
Submission Type

Other clearances by Card Guard Scientific Survival , Ltd.

  • K111745 — KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER (August 1, 2011)
  • K110499 — CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR (April 6, 2011)
  • K101703 — MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, (July 13, 2010)
  • K101639 — CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR (June 25, 2010)
  • K083174 — HEALTHEPOD (December 17, 2009)
  • K082521 — EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM (January 16, 2009)
  • K081257 — CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR (May 29, 2008)
  • K071995 — CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR (December 18, 2007)
  • K061428 — PMP4 APPLICATION (October 16, 2006)
  • K061528 — SELFCHECK GLUCO (September 22, 2006)

Other clearances for product code BZH

  • K253180 — Microlife Digital Peak Flow Meter, Model PF200B (PF200B) (June 23, 2026)
  • K252802 — Peak Flow Meter (PF-10(BR-PEF231)) (May 29, 2026)
  • K241338 — Peak Flow Meter (December 31, 2024)
  • K232588 — Aluna 2 (November 25, 2024)
  • K230423 — Electronic Peak Flow Meter (February 23, 2024)
  • K222810 — TD-7301 Peak Flow meter (December 19, 2023)
  • K203196 — Peak flow meter (May 26, 2021)
  • K200832 — Safey Peak Flow Meter (July 30, 2020)
  • K193311 — Aluna (March 25, 2020)
  • K191239 — Smart Peak Flow Meter (December 6, 2019)

FDA data resources