Modified Models 2000W and 2000W Option H Apnea Mon

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

510(k) Number

K905575 ↗

FDA Product Code

BZQ

Device Class

Class II

Regulation

21 CFR Part 868.2375

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Edentrace Airflow 3171/Sleep Lab Airflow 3170

  Class II

  FDA 510(k) K913749 Active Cleared 2 Jul 1992

• Model 2000W Option H Configuration

  Class II

  FDA 510(k) K871302 Active Cleared 20 Apr 1987

• Edentrace Multi-Charter Model 3700

  Class I

  FDA 510(k) K883315 Active Cleared 28 Dec 1988

• Edentec Model 2001 Modular Memory Unit (Mmu)

  Class II

  FDA 510(k) K892227 Active Cleared 20 Jun 1989

• Edentec Model 2860 Pressure Meter

  Class II

  FDA 510(k) K891540 Active Cleared 1 Jun 1989

• Edentrace 670 System Multichannel Recorder W/Oxim.

  Class I

  FDA 510(k) K893561 Active Cleared 25 Aug 1989

See all devices from Edentec Corp. →

• What is the MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON used for?

  This device is designed to monitor breathing frequency for the detection of apnea events in clinical settings, specifically within the medical specialty of anesthesiology, as defined by its nomenclature as a Breathing Frequency Monitor.

• How was the MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON cleared for market?

  The device received traditional clearance through the FDA 510(k) process under submission K905575, determined to be substantially equivalent to a predicate device, and is classified as a Class II medical device.

• What regulatory classification and product code apply to this apnea monitor?

  The device is classified as Class II with product code BZQ and regulation number 868.2375, reflecting its categorization as a Breathing Frequency Monitor under FDA device classification rules.