Optical Tracking System (Ots)
FDA 510(k) K001950 · Radionics, Inc.
510(k) numberK001950
Submission
- Device name
- Optical Tracking System (Ots)
- Applicant
- Radionics, Inc.
Burlington, MA, US - Received
- June 27, 2000
- Decision date
- July 26, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Optical Tracking System (Ots) cleared by the FDA?
Optical Tracking System (Ots) (K001950) received a 510(k) decision of Substantially Equivalent on July 26, 2000, 29 days after the submission was received.
What is the product code of K001950?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.