Carbon Fiber Couch Insert
FDA 510(k) K950068 · Medtec, Inc.
510(k) numberK950068
Submission
- Device name
- Carbon Fiber Couch Insert
- Applicant
- Medtec, Inc.
Orange City, IA, US - Received
- January 9, 1995
- Decision date
- April 6, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Carbon Fiber Couch Insert cleared by the FDA?
Carbon Fiber Couch Insert (K950068) received a 510(k) decision of Substantially Equivalent on April 6, 1995, 87 days after the submission was received.
What is the product code of K950068?
The FDA product code is KXJ – Table, Radiologic, a Class II (moderate risk) device regulated under 21 CFR 892.1980.