Cleared Traditional

IMPEDANCE TESTER (MODEL 4390) (K760776) - FDA 510(k) Clearance

K760776 · Cambridge Instruments, Inc. · Cardiovascular device
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Oct 1976
Decision
4d
Days
-
Risk

K760776 is an FDA 510(k) clearance for the IMPEDANCE TESTER (MODEL 4390).

Submitted by Cambridge Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 8, 1976 after a review of 4 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 Cambridge Instruments, Inc. devices

Submission Details

510(k) Number K760776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1976
Decision Date October 08, 1976
Days to Decision 4 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 125d · This submission: 4d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -