Model 375 ECG
by Birtcher Corp. 510(k)
Active
510(k) K881328
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK881328 | Date18 May 1988 | 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- Withdrawn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
- DPS
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2340
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The Model 375 ECG is an electrocardiograph device used for recording the electrical activity of the heart. It is designed to acquire, display, and store ECG waveforms for diagnostic evaluation.
The device is supplied as a reusable system intended for use in clinical settings such as hospitals and physician offices. It requires connection to patient electrodes and operates under standard environmental conditions; no sterility, single-use, MRI safety, or storage specifications are provided in the data. Authorization is based on FDA 510(k) clearance under product code DPS, with a traditional review pathway and cardiovascular advisory committee involvement.
Other devices from Birtcher Corp.
Questions
AI-generated answers, 21 Sep 2026
What is the Model 375 ECG used for?
The Model 375 ECG is used to record the electrical activity of the heart by acquiring, displaying, and storing ECG waveforms for diagnostic evaluation in clinical settings such as hospitals and physician offices.
Is the Model 375 ECG a single-use or reusable device?
The Model 375 ECG is supplied as a reusable system, meaning it is designed for multiple uses after appropriate cleaning and maintenance, not for single-use disposal.
Does the Model 375 ECG require sterile conditions or come sterile?
No sterility specifications are provided for the Model 375 ECG in the device data, so it is not supplied sterile and does not require sterile handling for operation.
What regulatory pathway was used for the Model 375 ECG?
The Model 375 ECG received authorization through an FDA 510(k) clearance with a traditional review pathway, involving the cardiovascular advisory committee, and was found substantially equivalent to a predicate device.
What are the storage or environmental requirements for the Model 375 ECG?
No specific storage or environmental conditions are specified in the device data for the Model 375 ECG; it operates under standard environmental conditions as used in clinical settings.