Apex Medical Xt Auto Cpap 9S-005200

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

510(k) Number

K083656 ↗

FDA Product Code

BZD

Device Class

Class II

Regulation

21 CFR Part 868.5905

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Apex Medical Minineb & Miniplus

  Class II

  FDA 510(k) K050104 Active Cleared 16 Feb 2005

• Apex Suction Curette

  Class I

  FDA 510(k) K871384 Active Cleared 22 May 1987

• Acu-Stim Tens, Ap-101082T

  Class II

  FDA 510(k) K973980 Active Cleared 29 Jul 1998

• Apex Medical Digital TENS TS1211, TS1212

  Class II

  FDA 510(k) K021755 Active Cleared 12 Jun 2002

• WiZARD 510 Nasal Mask

  Class II

  FDA 510(k) K193206 Active Cleared 29 Oct 2020

• Micro II Microcurrent Tens

  Class II

  FDA 510(k) K973978 Active Cleared 29 Jul 1998

See all devices from Apex Medical Corp. →