Skytron Elite 3500 Table
FDA 510(k) K940616 · Skytron, Div. the Kmw Group, Inc.
510(k) numberK940616
Submission
- Device name
- Skytron Elite 3500 Table
- Applicant
- Skytron, Div. the Kmw Group, Inc.
Grand Rapids, MI, US - Received
- February 14, 1994
- Decision date
- June 13, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GDC – Table, Operating-Room, Electrical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4960
- Specialty
- General, Plastic Surgery
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| K934744 | Midmark Magnum General Surgical TableGDC · Traditional | Midmark Corp. | 03/28/1994SE |
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| K915393 | Mdt/Shampaine Model 4900E Surgical TableGDC · Traditional | Mdt Corp., Inc. | 12/17/1991SE |
| K883613 | Oper. Table for Percutan. Trans. Coronary Angio.GDC · Traditional | Stierlen-Maquet AG | 09/15/1988SE |
| K853720 | Mobile Operating Table for Orl MicrosurgeryGDC · Traditional | Carl Zeiss, Inc. | 10/18/1985SE |
| K853480 | Skytron Elite 6000 & 6001 Surgical TablesGDC · Traditional | Skytron, Div. the Kmw Group, Inc. | 09/12/1985SE |
| K853535 | Trauma TableGDC · Traditional | Xre Corp. | 09/11/1985SE |
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Questions and answers
When was Skytron Elite 3500 Table cleared by the FDA?
Skytron Elite 3500 Table (K940616) received a 510(k) decision of Substantially Equivalent on June 13, 1994, 119 days after the submission was received.
What is the product code of K940616?
The FDA product code is GDC – Table, Operating-Room, Electrical, a Class I (low risk) device regulated under 21 CFR 878.4960.