Series 600 Patient Monitors
510(k) K844888
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK844888 | Date1 Feb 1985 | 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- Withdrawn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
- Full name
- Spacelabs Series 600 Patient Monitors
- 510(k) Number
- FDA Product Code
- DRT
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2300
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Series 600 Patient Monitors are cardiac monitoring devices designed to continuously measure and display vital signs such as heart rate, electrocardiogram (ECG), and other cardiovascular parameters. These monitors are classified as cardiac monitors, including cardiotachometers and rate alarms, and are intended for use in clinical settings to assess cardiac function and patient stability in real time.
These monitors are supplied as reusable medical devices and are intended for use in hospital or critical care environments. They are not classified as single-use or sterile devices, and their regulatory status includes FDA 510K clearance under the traditional pathway, with a decision date of February 1, 1985. The devices are categorized under the product code DRT and regulation number 870.2300, adhering to FDA guidelines for Class II medical devices.
Other devices from Spacelabs, Inc.
Questions
AI-generated answers, 1 Oct 2026
What are the Series 600 Patient Monitors designed to measure?
The Series 600 Patient Monitors are engineered to continuously measure and display vital cardiovascular parameters, including heart rate and electrocardiogram (ECG). These monitors provide real-time assessment of cardiac function, enabling clinicians to evaluate patient stability in clinical or critical care environments.
Are the Series 600 Patient Monitors reusable or single-use?
The Series 600 Patient Monitors are classified as reusable medical devices. They are intended for repeated use in hospital or critical care settings, where durability and consistent performance are essential for ongoing patient monitoring.
What regulatory approval does the Series 600 Patient Monitors hold?
The Series 600 Patient Monitors hold FDA 510K clearance under the traditional pathway, with a decision date of February 1, 1985. This classification falls under product code DRT and regulation number 870.2300, adhering to FDA guidelines for Class II medical devices.
What environments are these monitors intended for?
These monitors are specifically designed for use in hospital or critical care environments. Their robust construction and continuous monitoring capabilities make them suitable for settings where real-time cardiac assessment is critical to patient care.
Are there different models or sizes available within the Series 600?
The Series 600 includes multiple registration numbers (e.g., 3008717264, 3026751377, etc.), which may correspond to different models or configurations. These variations are intended to accommodate diverse clinical needs within cardiovascular monitoring. For precise specifications, refer to the manufacturer’s documentation or contact Spacelabs, Inc.