Cleared Traditional

K001775 - ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM (FDA 510(k) Clearance)

K001775 · Zoe Medical, Inc. · Cardiovascular device

Jan 2001

Decision

214d

Days

Class 2

Risk

K001775 is an FDA 510(k) clearance for the ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM. This device is classified as a Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (Class II - Special Controls, product code DRT).

Submitted by Zoe Medical, Inc. (Topsfield, US). The FDA issued a Cleared decision on January 12, 2001, 214 days after receiving the submission on June 12, 2000.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K001775 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 12, 2000
Decision Date	January 12, 2001
Days to Decision	214 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF