Takeda Medical Auto. Ambu. Blood Press. METER/2420
510(k) K880079
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK880079 | Date31 Mar 1988 | StatusActive |
Recalls
No FDA recalls found in the data synced 24 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DSK
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1110
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
The Takeda Medical Auto. Ambu. Blood Press. Meter/2420 is an automated blood pressure monitoring device designed for cardiovascular applications. It is a Class II medical device that measures blood pressure automatically, providing accurate readings for clinical assessment.
This device is supplied by A&D Engineering, Inc. and is authorized under FDA 510K clearance with K number K880079. It is regulated under product code DSK and is intended for use in cardiovascular settings. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided in the data.
Other devices from A&D Engineering, Inc.
Questions
AI-generated answers, 23 Sep 2026
What is the Takeda Medical Auto. Ambu. Blood Press. Meter/2420 used for?
The Takeda Medical Auto. Ambu. Blood Press. Meter/2420 is an automated blood pressure monitoring device designed specifically for cardiovascular applications. It provides accurate blood pressure readings for clinical assessment in cardiovascular settings.
Is the Takeda Medical Auto. Ambu. Blood Press. Meter/2420 a single-use device or can it be reused?
The device data does not specify whether the Takeda Medical Auto. Ambu. Blood Press. Meter/2420 is designed for single-use or multiple reuse. No information regarding sterility or reprocessing instructions is provided in the available data.
What regulatory approvals does the Takeda Medical Auto. Ambu. Blood Press. Meter/2420 have?
The device is authorized under FDA 510K clearance with K number K880079. It is classified as a Class II medical device and regulated under product code DSK. The clearance was received on January 11, 1988, with a decision date of March 31, 1988.
What are the storage conditions for the Takeda Medical Auto. Ambu. Blood Press. Meter/2420?
No information regarding storage conditions is provided in the device data. Users should consult the manufacturer's instructions for specific storage requirements to maintain device functionality and accuracy.