510(k) K926333

CPR PLUS by Kells Medical, Inc. — Product Code LIX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 8, 1993
Date Received: December 16, 1992
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Aid, Cardiopulmonary Resuscitation
Device Class: Class II
Regulation Number: 870.5210
Review Panel: CV
Submission Type

CPR Aid device WITH feedback (visual, audio or both) on one or more CPR parameters (e.g., rate, depth, ventilation ratio, etc.), and contains software. Provides real-time feedback on CPR performance. Feedback can be audio, visual or both. Device contains software

Other clearances by Kells Medical, Inc.

K890093 — PVC EMPTY SOLUTION CONTAINER ENTERAL PUMP SET (July 24, 1989)
K890094 — EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET (May 24, 1989)
K890095 — PVC EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET (May 24, 1989)
K861972 — DERMISTRIP (June 27, 1986)
K844463 — DERMIDRESS (January 8, 1985)
K844072 — DERMIZIP SKIN CLOSURE DEVICE (November 5, 1984)
K832678 — PHONATORY FUNCTION ANALYZER PS-77 (March 7, 1984)
K832667 — LUCAE'S EAR & NASAL APPLICATORS (September 29, 1983)
K823118 — SAY (January 7, 1983)
K823227 — IMPEDANCE METER ON-1 (November 22, 1982)

Other clearances for product code LIX

K201581 — CPR BAND (March 6, 2021)
K183348 — Reusable Silicone Cover CPRmeter 2 (December 17, 2018)
K173886 — CPRmeter 2 CPR Feedback Device (March 23, 2018)
K151702 — Reusable Full Silicone Cover (August 13, 2015)
K123248 — CPR RSQ ASSIST (December 10, 2013)
K123597 — TRUECPR COACHING DEVICE (April 17, 2013)
K122050 — CPRMETER CPR FEEDBACK DEVICE (October 22, 2012)
K112660 — POCKETCPR (May 10, 2012)
K092408 — RHYTHM OF LIFE, MODEL R0901-05 (October 14, 2009)
K071321 — POCKETCPR (September 12, 2007)