Poly G Physiological Data Recorder

No FDA recalls found in the data synced 10 Oct 2026.

510(k) Number

K897107 ↗

FDA Product Code

BXO

Device Class

Class I

Regulation

21 CFR Part 868.2900

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Cerebral Tracer 1500 & CT 1.0 Software

  Class I

  FDA 510(k) K844015 Active Cleared 17 Dec 1984

• Breathe Right Nasal Strip

  Class I

  FDA 510(k) K953772 Active Cleared 20 Oct 1995

• Respi-Pak Rt-Pak

  Class II

  FDA 510(k) K910452 Active Cleared 16 Apr 1991

• Cns-Ep System and Ep 1.0 Software

  Class II

  FDA 510(k) K860240 Active Cleared 17 Apr 1986

• Cns Satellite 100, 200, 1000, 2000 Electroence.

  Class II

  FDA 510(k) K901549 Active Cleared 24 Oct 1990

• Sleep Test(Tm)

  Class II

  FDA 510(k) K950273 Active Cleared 19 Sep 1995

See all devices from Cns, Inc. →