SpectraShield 9500 Surgical N95 Respirator— 510(k) K150729

Name: FDA 510(k) clearance K150729
Creator: U.S. Food and Drug Administration
Published: 2015-12-29

Substantially Equivalent

Nexera Medical, Inc.

FDA 510(k) clearance K150729 for SpectraShield 9500 Surgical N95 Respirator, Substantially Equivalent on 2015-12-29. Applicant: Nexera Medical, Inc.. Device class: 2.

Clearance details

Applicant: Nexera Medical, Inc.
Product code: Code ONT
Device class: Class 2
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 2015-03-20
Decision date: 2015-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ft.Lauderdale, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ONT

view all

K122702 — BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR2013-03-18
K120244 — SPECTRASHIELD 9500 SURGICAL N95 RESPIRATOR2012-07-05
K090414 — SPECTRASHIELD 9500 SURGICAL MASK2011-02-24
K093161 — ACTIPROTECT UF N95 RESPIRATOR2010-05-10
K081923 — ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLD2009-07-01

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