Peerbridge Cor(TM) System

510(k)K171936CardiovascularDSH

Peerbridge Health INc. is listed for Peerbridge Cor(TM) System (K171936). The FDA list gives September 27, 2017 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is DSH. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K171936

Official FDA database record

Date of final decision: September 27, 2017
Company on the FDA list: Peerbridge Health INc.
Lead panel: Cardiovascular
Primary product code: DSH
openFDA device name for the code: Recorder, Magnetic Tape, Medical
Device class: 2
Regulation number: 870.2800
openFDA decision description: Substantially Equivalent
openFDA decision code: SESE
Statement or summary label: Summary