Percussor

• • Terminated Z-1515-2021 FDA Class II ·initiated 31 Mar 2021

  The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels.

510(k) Number

K812166 ↗

FDA Product Code

BYI

Device Class

Class II

Regulation

21 CFR Part 868.5665

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• T-Pieces Connectors

  Class I

  FDA 510(k) K860887 Active Cleared 19 Mar 1986

• Nasal Cannula W/2M & 5M Tubing

  Class I

  FDA 510(k) K860872 Active Cleared 19 Mar 1986

• Inspiratory Force Mont Kit/Manifold/Meter/Tubing

  Class II

  FDA 510(k) K873498 Active Cleared 9 Mar 1988

• Asthmakit

  Class II

  FDA 510(k) K874047 Active Cleared 29 Feb 1988

• Non-Rebreathing T Piece

  Class II

  FDA 510(k) K790820 Active Cleared 4 May 1979

• HOO2D Seat-Infant

  Class I

  FDA 510(k) K820640 Active Cleared 26 Mar 1982

See all devices from Dhd Medical Products Div. Diemolding Corp. →