Cleared Traditional

K991014 - CASE 8000 EXERCISE TESTING SYSTEM

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.

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FDA 510(k) Submission Details - K991014

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 125d · This submission: 208d
Pathway characteristics
Predicate-based equivalence.

LOS Device Classification - Class ,

Product Code LOS
Device Class -

Regulatory Peers - LOS

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