PMP4 Application
by Card Guard Scientific Survival, Ltd.
510(k) K061428
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK061428 | Date16 Oct 2006 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MSX
- FDA applicant
- Card Guard Scientific Survival , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2300
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The PMP4 Application is a physiological monitor system designed for network and communication purposes. It functions as a cardiovascular device within the clinical environment.
This device is authorized under FDA 510(k) clearance K061428. It is classified as a Class 2 device under regulation number 870.2300.
Other devices from Card Guard Scientific Survival, Ltd.
Questions
AI-generated answers, 21 Sep 2026
What is the primary function of the PMP4 Application?
The PMP4 Application is a physiological monitor system intended for use within clinical environments. It is specifically designed to facilitate network and communication functions for cardiovascular monitoring.
What is the regulatory status of this device?
The PMP4 Application is authorized under FDA 510(k) clearance K061428. It is classified as a Class 2 medical device under regulation number 870.2300.
Which medical specialty is this device associated with?
The device is categorized under the cardiovascular medical specialty, as indicated by its classification and advisory committee designation.