Bomed-Eea

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K853705 ↗

FDA Product Code

DRX

Device Class

Class II

Regulation

21 CFR Part 870.2360

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Bo Med Bia

  Class II

  FDA 510(k) K811999 Active Cleared 31 Aug 1981

• Pulsette 110 Transcutaneous Elec-Nerve

  Class II

  FDA 510(k) K830792 Active Cleared 29 Mar 1983

• Additional Software to Cardiodynamic Monitor

  Class II

  FDA 510(k) K890408 Active Cleared 1 Jun 1989

• Bioflow

  Class II

  FDA 510(k) K831422 Active Cleared 12 Sep 1983

• Bomed Biocon

  Class II

  FDA 510(k) K831421 Active Cleared 12 Sep 1983

• Bomed-Nccom

  Class II

  FDA 510(k) K813020 Active Cleared 14 Dec 1981

See all devices from Bomed Medical Mfr., Ltd. →