DSPS-Prominent Masks; DSPS-Prominent Baseplate, MR; CouchStrip— 510(k) K222977

Substantially Equivalent

Macromedics BV

FDA 510(k) clearance K222977 for DSPS-Prominent Masks; DSPS-Prominent Baseplate, MR; CouchStrip, Substantially Equivalent on 2023-02-17. Applicant: Macromedics BV.

Clearance details

Applicant: Macromedics BV
Product code: Code IYE
Advisory panel: Radiology
Date received: 2022-09-28
Decision date: 2023-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Moordrecht, NL

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.