FDA 510(k) clearance · back to tracker

ONESTEP PEDIATRIC MFE'S

ZOLL Medical Corporation cleared K110978 on 2011-05-13, decision: substantially equivalent

K-number

K110978

Sponsor

ZOLL Medical Corporation

Device

ONESTEP PEDIATRIC MFE'S

Class

Class III

Decision

Substantially Equivalent

Decision date

2011-05-13

Product code

MKJ

Advisory committee

Cardiovascular

Medical specialty

Cardiovascular

Regulation number

870.5310

Official FDA record

Open K110978on 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 K110978 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.