Conphar Checkmate Sphygmomanometer
by Conphar, Inc. 510(k)
Active
510(k) K801187
Overview
The Conphar Checkmate Sphygmomaneter is a system for non-invasive measurement of blood pressure. It is classified under product code DXN as a System, Measurement, Blood-pressure, Non-invasive medical device.
This device is manufactured by Conphar, Inc. and was submitted for FDA 510(k) clearance on May 19, 1980, receiving a Substantially Equivalent decision on June 9, 1980. It is reviewed under the Cardiovascular specialty and classified as Class II - Special Controls.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK801187 | Date9 Jun 1980 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DXN
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1130
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Conphar, Inc.
Questions
What is the Conphar Checkmate Sphygmomanometer used for?
The Conphar Checkmate Sphygmomanometer is a medical device designed for non-invasive measurement of blood pressure. It provides clinicians with a reliable method to monitor patients' blood pressure levels without invasive procedures.
Is the Conphar Checkmate Sphygmomanometer a single-use or reusable device?
The device information does not specify whether the Conphar Checkmate Sphygmomanometer is designed for single-use or multiple uses. For proper usage instructions and disposal guidelines, please refer to the manufacturer's documentation or contact Conphar, Inc. directly.
What regulatory approvals does the Conphar Checkmate Sphygmomanometer have?
The Conphar Checkmate Sphygmomaneter received FDA 510(k) clearance on June 9, 1980, after being submitted on May 19, 1980. It was determined to be Substantially Equivalent and is classified as a Class II device under Special Controls, reviewed by the Cardiovascular specialty advisory committee.
What are the available sizes or models of the Conphar Checkmate Sphygmomanometer?
The device data does not specify different sizes or models of the Conphar Checkmate Sphygmomanometer. For information about available configurations or variations, please contact the manufacturer Conphar, Inc. directly or consult the product documentation.