SLANT/FIN HEPA CLEAR— 510(k) K953536

Substantially Equivalent

Amcor, Ltd.

FDA 510(k) clearance K953536 for SLANT/FIN HEPA CLEAR, Substantially Equivalent on 1995-10-30. Applicant: Amcor, Ltd.. Device class: 2.

Clearance details

Applicant: Amcor, Ltd.
Product code: Code FRF
Device class: Class 2
Regulation: 21 CFR 880.5045
Advisory panel: General Hospital
Date received: 1995-07-27
Decision date: 1995-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Long Island City, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FRF

K251872 — Biomoneta Avata Rx2025-11-14
K242102 — CerroZone Mini2024-11-19
K240696 — Airdog X8 Air Purifier (KJ800F-X8)2024-06-14
K223835 — MA-40, MA-1122023-09-18
K222416 — RIA Safeguard2023-05-01

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