Cosman Robert Wells Functional Probe Microdrive
FDA 510(k) K992721 · Radionics, Inc.
510(k) numberK992721
Submission
- Device name
- Cosman Robert Wells Functional Probe Microdrive
- Applicant
- Radionics, Inc.
Burlington, MA, US - Received
- August 13, 1999
- Decision date
- September 10, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Cosman Robert Wells Functional Probe Microdrive cleared by the FDA?
Cosman Robert Wells Functional Probe Microdrive (K992721) received a 510(k) decision of Substantially Equivalent on September 10, 1999, 28 days after the submission was received.
What is the product code of K992721?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.