Peerbridge Cor(TM) System is an AI-enabled medical device from Peerbridge Health INc. that the U.S. FDA cleared through 510(k) K171936 on September 27, 2017. Its lead review panel is Cardiovascular and its primary product code is DSH (Recorder, Magnetic Tape, Medical).
See also FDA-cleared AI cardiovascular devices in 2017, all FDA AI clearances in 2017, top cardiovascular AI devices.
Key facts
| Submission number | K171936 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Peerbridge Health INc. |
| Lead review panel | Cardiovascular |
| Primary product code | DSH — Recorder, Magnetic Tape, Medical |
| Applicant (openFDA) | Peerbridge Health, Inc. |
| Applicant location | New York, NY, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 870.2800 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. Peerbridge Cor(TM) System went through this pathway (K171936).
openFDA lists it as a Class 2 device under 21 CFR 870.2800. Class II devices are moderate risk and are subject to general and special controls.
Product code DSH covers 2 devices on the FDA AI list. By decision date, this device is #1 of 2 under that code. Peerbridge Health INc. has 1 AI-enabled device on the list, and the Cardiovascular panel accounts for 154 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.