Cleared Traditional

K892227 - EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU) (FDA 510(k) Clearance)

K892227 · Edentec Corp. · Cardiovascular device

Jun 1989

Decision

77d

Days

Class 2

Risk

K892227 is an FDA 510(k) clearance for the EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU). This device is classified as a Recorder, Magnetic Tape, Medical (Class II - Special Controls, product code DSH).

Submitted by Edentec Corp. (Eden Prairie, US). The FDA issued a Cleared decision on June 20, 1989, 77 days after receiving the submission on April 4, 1989.

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

Submission Details

510(k) Number	K892227 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 04, 1989
Decision Date	June 20, 1989
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—