Cleared Traditional

K871218 - MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT
(FDA 510(k) Clearance)

K871218 · Hospal Medical Corp. · Gastroenterology & Urology

Apr 1987

Decision

34d

Days

Class 2

Risk

K871218 is an FDA 510(k) clearance for the MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT. This device is classified as a System, Dialysate Delivery, Single Patient (Class II — Special Controls, product code FKP).

Submitted by Hospal Medical Corp. (Edison, US). The FDA issued a Cleared decision on April 30, 1987, 34 days after receiving the submission on March 27, 1987.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.

Submission Details

510(k) Number	K871218 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 27, 1987
Decision Date	April 30, 1987
Days to Decision	34 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	—