BREAST TREATMENT AID— 510(k) K961170

Substantially Equivalent

S. and H. Engineering, Inc.

FDA 510(k) clearance K961170 for BREAST TREATMENT AID, Substantially Equivalent on 1996-06-19. Applicant: S. and H. Engineering, Inc..

Clearance details

Applicant: S. and H. Engineering, Inc.
Product code: Code IYE
Advisory panel: Radiology
Date received: 1996-03-25
Decision date: 1996-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

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.