Sapphire Series 1P, 1l, 2l, and 2ME

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K903731 ↗

FDA Product Code

GWF

Device Class

Class II

Regulation

21 CFR Part 882.1870

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• P460, DG32 Electroencephalograph

  Class II

  FDA 510(k) K896666 Active Cleared 16 Feb 1990

• Teca TC2-64 Transcranial Doppler

  Class II

  FDA 510(k) K850137 Active Cleared 14 Aug 1985

• Reversing Click Generator RCG6

  Class II

  FDA 510(k) K771188 Active Cleared 14 Jul 1977

• ST10 Progr. Evoked Response Stimulator

  Class II

  FDA 510(k) K822744 Active Cleared 3 Nov 1982

• Teca Montage II

  Class II

  FDA 510(k) K851232 Active Cleared 13 Jun 1985

• Teca/Medelec Mistral Photic Stimulator

  Class II

  FDA 510(k) K880593 Active Cleared 6 Apr 1988

See all devices from Teca, Inc. →