Model 78801A Patient Monitors
by Hewlett-Packard Co. 510(k)
Active
510(k) K790454
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK790454 | Date3 Apr 1979 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- DRT
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2300
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The Model 78801a Patient Monitors is a cardiac monitor, including cardiotachometer and rate alarm, classified as a device class 2. It is used in the medical specialty of cardiovascular care.
The device is supplied by Hewlett-Packard Co. and has a product code of DRT, with a regulation number of 870.2300. It has been cleared with a Traditional clearance type and is classified as substantially equivalent.
Other devices from Hewlett-Packard Co.
Questions
AI-generated answers, 22 Sep 2026
What is the Model 78801a Patient Monitors used for?
The Model 78801a Patient Monitors is used in the medical specialty of cardiovascular care, specifically as a cardiac monitor, including cardiotachometer and rate alarm.
Who supplies the Model 78801a Patient Monitors?
The device is supplied by Hewlett-Packard Co.
What is the product code of the Model 78801a Patient Monitors?
The product code of the Model 78801a Patient Monitors is DRT, with a regulation number of 870.2300.
Is the Model 78801a Patient Monitors a single-use or reusable device?
The device data does not specify whether the Model 78801a Patient Monitors is single-use or reusable.
What is the regulatory classification of the Model 78801a Patient Monitors?
The Model 78801a Patient Monitors is classified as a device class 2, and has been cleared with a Traditional clearance type.