NESSI OTC SPACER— 510(k) K101532

Substantially Equivalent

Pharmacaribe

FDA 510(k) clearance K101532 for NESSI OTC SPACER, Substantially Equivalent on 2010-09-01. Applicant: Pharmacaribe. Device class: 2.

Clearance details

Applicant: Pharmacaribe
Product code: Code NVO
Device class: Class 2
Regulation: 21 CFR 868.5630
Advisory panel: Anesthesiology
Date received: 2010-06-03
Decision date: 2010-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonita Springs, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NVO

K091862 — NESSI SPACER2009-11-20

More clearances from Pharmacaribe

K130091 — PULMOSAL2013-03-13
K101424 — PHARMACARIBE INHALED SALINE SOLUTIONS2010-08-17

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