Home / 510(k) Clearances / K193311

510(k) K193311

Aluna by Knox Medical Diagnostics, Inc. — Product Code BZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2020
Date Received
November 29, 2019
Clearance Type
Traditional
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 Knox Medical Diagnostics, Inc.

  • K232588 — Aluna 2 (November 25, 2024)

Other clearances for product code BZH

  • 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)
  • K191239 — Smart Peak Flow Meter (December 6, 2019)
  • K180487 — Peak.me (October 26, 2018)
  • K181666 — Smart One (August 1, 2018)
  • K172804 — Besmed Peak Flow Meter (January 11, 2018)