Cleared Traditional

EPISENSOR PLUS

K920740 · Industrias Palex C/O Dma Med-Chem Corp. · General Hospital
Mar 1994
Decision
747d
Days
Class 2
Risk

About This 510(k) Submission

K920740 is an FDA 510(k) clearance for the EPISENSOR PLUS, a Monitor, Spinal-fluid Pressure, Electrically Powered (Class II — Special Controls, product code CAR), submitted by Industrias Palex C/O Dma Med-Chem Corp. (Spain, ES). The FDA issued a Cleared decision on March 7, 1994, 747 days after receiving the submission on February 19, 1992. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2460.

Submission Details

510(k) Number K920740 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 1992
Decision Date March 07, 1994
Days to Decision 747 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code CAR — Monitor, Spinal-fluid Pressure, Electrically Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.2460