Optical Tracking System Microscope Module II, Model Ots Mmii

Q: What is the product code of K990326?

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

FDA 510(k) K990326 · Radionics Software Applications, Inc.

Substantially Equivalent

510(k) numberK990326

Submission

Device name: Optical Tracking System Microscope Module II, Model Ots Mmii
Applicant: Radionics Software Applications, Inc.
Burlington, MA, US
Received: February 2, 1999
Decision date: March 4, 1999
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 Optical Tracking System Microscope Module II, Model Ots Mmii cleared by the FDA?

Optical Tracking System Microscope Module II, Model Ots Mmii (K990326) received a 510(k) decision of Substantially Equivalent on March 4, 1999, 30 days after the submission was received.

What is the product code of K990326?

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