Reflective Sphere Standard Probe and Reflective Sphere Dynamic Reference Frame

Q: What is the product code of K983603?

The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.

FDA 510(k) K983603 · Radionics, Inc.

Substantially Equivalent

510(k) numberK983603

Submission

Device name: Reflective Sphere Standard Probe and Reflective Sphere Dynamic Reference Frame
Applicant: Radionics, Inc.
Burlington, MA, US
Received: October 14, 1998
Decision date: November 10, 1998
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: HAW – Neurological Stereotaxic Instrument
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.4560
Specialty: Neurology

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Questions and answers

When was Reflective Sphere Standard Probe and Reflective Sphere Dynamic Reference Frame cleared by the FDA?

Reflective Sphere Standard Probe and Reflective Sphere Dynamic Reference Frame (K983603) received a 510(k) decision of Substantially Equivalent on November 10, 1998, 27 days after the submission was received.

What is the product code of K983603?

The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.