Fuzzy Automatic Blood Pressure Monitor Models MD-750, MD-770, MD-800

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

510(k) Number

K992328 ↗

FDA Product Code

DXN

Models / Variants

Md-750

Md-770

Md-800

Device Class

Class II

Regulation

21 CFR Part 870.1130

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Meditec Co., Ltd. →

• What are the primary uses for the Fuzzy Automatic Blood Pressure Monitor (Models MD-750, MD-770, MD-800) in clinical and home settings?

  The Fuzzy Automatic Blood Pressure Monitor (Models MD-750, MD-770, MD-800) is designed specifically for noninvasive measurement of systolic and diastolic blood pressure, as well as heart rate determination in adults. It is intended for use in both clinical environments (like hospitals or doctor’s offices) and home settings, allowing patients to monitor their blood pressure independently.

• Are these devices single-use or reusable, and what does that mean for maintenance?

  These devices are reusable electronic instruments, meaning they are not disposable. Since they are not single-use, proper maintenance and cleaning protocols must be followed to ensure accuracy and hygiene over repeated use. The manufacturer’s instructions (not provided in the data) should outline recommended cleaning procedures.

• What models are included in the Fuzzy Automatic Blood Pressure Monitor series, and are there differences between them?

  The series includes three models: MD-750, MD-770, and MD-800. While the data does not specify technical differences between them, the models are all classified under the same product code (DXN) for noninvasive blood pressure measurement. For exact features or performance distinctions, refer to Meditec Co., Ltd.’s product documentation.

• How was the regulatory pathway for this device determined, and what does that mean for its approval status?

  The device was cleared via the traditional 510(k) pathway under FDA regulation, classified as Class II with special controls (Regulation Number 870.1130). This means it was deemed substantially equivalent to a legally marketed predicate device after review by the FDA’s Cardiovascular (CV) advisory committee. The clearance date was July 21, 1999, confirming its compliance with U.S. regulatory standards at that time.