FDA 510(k) clearance · back to tracker

HEART SYNC

Heart Sync, Inc. cleared K131550 on 2013-12-06, decision: substantially equivalent

K-number

K131550

Sponsor

Heart Sync, Inc.

Device

HEART SYNC

Class

Class III

Decision

Substantially Equivalent

Decision date

2013-12-06

Product code

MKJ

Advisory committee

Cardiovascular

Medical specialty

Cardiovascular

Regulation number

870.5310

Official FDA record

Open K131550on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

Use this as a predicate

Drop K131550 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

Try the sandbox

Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.