Cleared Traditional

K101022 - PULMOTRACK 5050 WHOLTER, MODEL 5050
(FDA 510(k) Clearance)

K101022 · Karmelsonix · Cardiovascular
Jul 2010
Decision
87d
Days
Class 2
Risk

K101022 is an FDA 510(k) clearance for the PULMOTRACK 5050 WHOLTER, MODEL 5050. This device is classified as a Recorder, Magnetic Tape, Medical (Class II — Special Controls, product code DSH).

Submitted by Karmelsonix (Binyamina, IL). The FDA issued a Cleared decision on July 9, 2010, 87 days after receiving the submission on April 13, 2010.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number K101022 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 2010
Decision Date July 09, 2010
Days to Decision 87 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSH — Recorder, Magnetic Tape, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2800