Meditech ABPM-06 (BP6)

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K201332 ↗

FDA Product Code

DXN

FDA applicant

Meditech , Ltd.

Device Class

Class II

Regulation

21 CFR Part 870.1130

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Hypodermic Needles & Syringes

  Class I

  FDA 510(k) K821348 Active Cleared 10 Jun 1982

• Medi-Tech Dilatation Catheters

  Class II

  FDA 510(k) K843383 Active Cleared 24 Oct 1984

• Catheter, External Male Nursing Care

  Class II

  FDA 510(k) K781780 Active Cleared 7 Dec 1978

• Catheter, Transluminal Balloon

  Class I

  FDA 510(k) K781772 Active Cleared 6 Mar 1979

• Enter-A1 Enteric Feeding Tube

  Class II

  FDA 510(k) K812279 Active Cleared 25 Aug 1981

• Coagulation Reference Plasma, Abnormal

  Class II

  FDA 510(k) K904073 Active Cleared 22 Oct 1990

See all devices from Medi-Tech, Inc. →

• What is the Meditech ABPM-06 (BP6) used for?

  The Meditech ABPM-06 (BP6) is designed for non-invasive ambulatory blood pressure monitoring. It continuously measures and records blood pressure over extended periods outside clinical settings, helping to assess hypertension or other cardiovascular conditions by providing a detailed blood pressure profile. The stepwise deflation method ensures precise readings, making it ideal for long-term patient monitoring.

• How is the Meditech ABPM-06 (BP6) supplied, and what accessories are included?

  The Meditech ABPM-06 (BP6) is supplied with compatible blood pressure cuffs to ensure accurate measurements. It integrates with Meditech’s Windows-based software, which facilitates data analysis and reporting. The device’s lightweight and compact design is also included to enhance patient comfort during extended wear.

• Is the Meditech ABPM-06 (BP6) single-use or reusable?

  The Meditech ABPM-06 (BP6) can be used for either single-use or reusable applications, depending on the manufacturer’s guidelines. These guidelines typically outline cleaning and maintenance procedures to ensure device reliability and accuracy. Always follow the provided instructions to determine the appropriate use case for your clinical setting.

• What storage requirements does the Meditech ABPM-06 (BP6) have?

  The Meditech ABPM-06 (BP6) does not require special storage conditions beyond those specified in the accompanying instructions. Standard environmental conditions should suffice, but it’s important to refer to the manufacturer’s guidelines to ensure optimal performance and longevity of the device.

• Is the Meditech ABPM-06 (BP6) compatible with MRI environments?

  The available data does not specify whether the Meditech ABPM-06 (BP6) is compatible with MRI environments. If MRI compatibility is a requirement for your clinical setting, it is recommended to consult the manufacturer directly or review additional documentation to confirm safe usage.