Cleared Traditional

K790644 - SUBMAX
(FDA 510(k) Clearance)

K790644 · Chase Mfg. Co. · Cardiovascular

Apr 1979

Decision

27d

Days

Class 2

Risk

K790644 is an FDA 510(k) clearance for the SUBMAX, a Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (Class II — Special Controls, product code DRT), submitted by Chase Mfg. Co. (Mchenry, US). The FDA issued a Cleared decision on April 26, 1979, 27 days after receiving the submission on March 30, 1979. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K790644 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 30, 1979
Decision Date	April 26, 1979
Days to Decision	27 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—