Remote Introducer, Model PI-1000
FDA 510(k) K990907 · Image-Guided Neurologics, Inc.
510(k) numberK990907
Submission
- Device name
- Remote Introducer, Model PI-1000
- Applicant
- Image-Guided Neurologics, Inc.
Melbourne, FL, US - Received
- March 18, 1999
- Decision date
- August 12, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Remote Introducer, Model PI-1000 cleared by the FDA?
Remote Introducer, Model PI-1000 (K990907) received a 510(k) decision of Substantially Equivalent on August 12, 1999, 147 days after the submission was received.
What is the product code of K990907?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.