Cleared Traditional

K991014 - CASE 8000 EXERCISE TESTING SYSTEM (FDA 510(k) Clearance)

K991014 · General Electric Medical Systems Information Techn · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
208d
Days
-
Risk

K991014 is an FDA 510(k) clearance for the CASE 8000 EXERCISE TESTING SYSTEM.

Submitted by General Electric Medical Systems Information Techn (Milwaukee, US). The FDA issued a Cleared decision on October 20, 1999 after a review of 208 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all General Electric Medical Systems Information Techn devices

Submission Details

510(k) Number K991014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1999
Decision Date October 20, 1999
Days to Decision 208 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 125d · This submission: 208d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -