GE Healthcare Insta Trak 3500PLUS/ Fluoro Trak 9800 Plus System with Axcess Bone Pin, Model Part # 1006955
FDA 510(k) K051734 · Ge Healthcare Technologies
510(k) numberK051734
Submission
- Device name
- GE Healthcare Insta Trak 3500PLUS/ Fluoro Trak 9800 Plus System with Axcess Bone Pin, Model Part # 1006955
- Applicant
- Ge Healthcare Technologies
Lawrence, MA, US - Received
- June 28, 2005
- Decision date
- November 23, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was GE Healthcare Insta Trak 3500PLUS/ Fluoro Trak 9800 Plus System with Axcess Bone Pin, Model Part # 1006955 cleared by the FDA?
GE Healthcare Insta Trak 3500PLUS/ Fluoro Trak 9800 Plus System with Axcess Bone Pin, Model Part # 1006955 (K051734) received a 510(k) decision of Substantially Equivalent on November 23, 2005, 148 days after the submission was received.
What is the product code of K051734?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.