Home / 510(k) Clearances / K223818

510(k) K223818

Model 9160 VitaloQUB by Vitalograph Ireland, Ltd. — Product Code JEH

K223818 is an FDA 510(k) premarket notification submitted by Vitalograph Ireland, Ltd. for the device "Model 9160 VitaloQUB". The FDA issued a decision of Substantially Equivalent on May 25, 2023. The device falls under product code JEH (Plethysmograph, Volume), a Class II device regulated under 21 CFR 868.1760. Vitalograph Ireland, Ltd. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2023
Date Received
December 21, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plethysmograph, Volume
Device Class
Class II
Regulation Number
868.1760
Review Panel
AN
Submission Type

Other clearances by Vitalograph Ireland, Ltd.

  • K221030 — Model 9100 PFT/DICO (July 15, 2022)
  • K212938 — Vitalograph Model 6000 Alpha (January 26, 2022)
  • K201562 — Spirotrac (October 14, 2020)
  • K200550 — Vitalograph Model 2120 In2itive eDiary (July 27, 2020)

Other clearances for product code JEH

  • K240706 — PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); P (December 9, 2024)
  • K072061 — MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY (April 22, 2008)
  • K022636 — BODY BOX 5500 (January 13, 2003)
  • K960840 — C.E. VASCULAR MACHINE (March 28, 1997)
  • K953642 — AP-18 (December 12, 1995)
  • K951901 — MASTERSCREEN PFT BODY (July 31, 1995)
  • K936108 — MASTERSCREEN BODY (February 3, 1995)
  • K932812 — EC 5R PLETHYSMOGRAPH (January 13, 1994)
  • K925040 — TELEPULSE (August 23, 1993)
  • K851197 — CYBERMEDIC CM-810 BODY PLETHYSMOGRAPH (July 8, 1985)

FDA data resources