Cleared Traditional

K760559 - PATIENT MONITORING SYSTEM (FDA 510(k) Clearance)

K760559 · General Electric Co. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1976
Decision
8d
Days
-
Risk

K760559 is an FDA 510(k) clearance for the PATIENT MONITORING SYSTEM.

Submitted by General Electric Co. (Mchenry, US). The FDA issued a Cleared decision on September 10, 1976 after a review of 8 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all General Electric Co. devices

Submission Details

510(k) Number K760559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1976
Decision Date September 10, 1976
Days to Decision 8 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 125d · This submission: 8d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -