DQH · Cardiograph, Apex (Vibrocardiograph)
Cardiovascular · 21 CFR 870.2310 · Class 2
Overview
| Product Code | DQH |
|---|---|
| Device Name | Cardiograph, Apex (Vibrocardiograph) |
| Regulation | 21 CFR 870.2310 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
An apex cardiograph (vibrocardiograph) is a device used to amplify or condition the signal from an apex cardiographic transducer and to produce a visual display of the motion of the heart; this device also provides any excitation energy required by the transducer.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K974697 | REUSABLE FINGER SENSOR 3444 | Bci Intl., Inc. | Mar 11, 1998 | SESE |
Top Applicants
- Bci Intl., Inc. — 1 clearance
