WATCH-PAT 200I (WP200I)— 510(k) K081037

Substantially Equivalent

Itamar Medical

FDA 510(k) clearance K081037 for WATCH-PAT 200I (WP200I), Substantially Equivalent on 2008-06-09. Applicant: Itamar Medical. Device class: 2.

Clearance details

Applicant: Itamar Medical
Product code: Code MNR
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2008-04-11
Decision date: 2008-06-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MNR

More clearances from Itamar Medical

K081982 — WATCH-PAT 200S-2 (WP200S-2)2008-08-14
K080427 — WATCH-PAT MODEL 100S-22008-05-23
K042916 — WATCH PAT 100S2004-12-29
K032519 — ENDO PAT 20002003-11-12

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