Hewlett Packard Model 5650C, Cardio Data Mgmt Syst
by Hewlett-Packard Co. 510(k)
Active
510(k) K905100
Overview
The Hewlett Packard Model 5650C is a programmable diagnostic computer designed for cardiology data management. It functions as a system for processing and organizing cardiovascular information.
This device received FDA 510(k) clearance under K905100. It is classified as a Class II device under product code DQK.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK905100 | Date15 Jan 1991 | 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- Withdrawn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
- DQK
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1425
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Hewlett-Packard Co.
Questions
What is the primary function of the Hewlett Packard 5650C?
The 5650C is a programmable diagnostic computer specifically engineered for cardiology data management. It serves as a centralized system to process and organize cardiovascular information within a clinical environment.
What is the regulatory status of this device?
The Hewlett Packard 5650C received FDA 510(k) clearance under K905100. It is classified as a Class II device under product code DQK, indicating it has been found substantially equivalent to other legally marketed devices.
Which advisory committee oversees this device category?
This device is categorized under the Cardiovascular advisory committee, which is responsible for reviewing systems and equipment related to heart and vascular health diagnostics.