Stryker COMMAND2 Office Console
FDA 510(k) K953071 · Stryker Instruments
510(k) numberK953071
Submission
- Device name
- Stryker COMMAND2 Office Console
- Applicant
- Stryker Instruments
Kalamazoo, MI, US - Received
- June 30, 1995
- Decision date
- August 8, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JEA – Table, Surgical With Orthopedic Accessories, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4960
- Specialty
- General, Plastic Surgery
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Questions and answers
When was Stryker COMMAND2 Office Console cleared by the FDA?
Stryker COMMAND2 Office Console (K953071) received a 510(k) decision of Substantially Equivalent on August 8, 1995, 39 days after the submission was received.
What is the product code of K953071?
The FDA product code is JEA – Table, Surgical With Orthopedic Accessories, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 878.4960.