Mdt/Shampaine Model 4900E Surgical Table
FDA 510(k) K915393 · Mdt Corp., Inc.
510(k) numberK915393
Submission
- Device name
- Mdt/Shampaine Model 4900E Surgical Table
- Applicant
- Mdt Corp., Inc.
Rochester, NY, US - Received
- November 29, 1991
- Decision date
- December 17, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
Other 510(k)s with product code GDC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K971390 | Quantum 3080SP Surgical TableGDC · Traditional | STERIS Corporation | 05/15/1997SE |
| K970807 | Mobile Operating Table 1132.01GDC · Traditional | Stierlen-Maquet AG | 03/14/1997SE |
| K964273 | Dura-Board ArmboardGDC · Traditional | Allen Medical Systems, Inc. | 01/08/1997SE |
| K940616 | Skytron Elite 3500 TableGDC · Traditional | Skytron, Div. the Kmw Group, Inc. | 06/13/1994SE |
| K934744 | Midmark Magnum General Surgical TableGDC · Traditional | Midmark Corp. | 03/28/1994SE |
| K914758 | Mdt/Shampaine Model 4900B Surgical TableGDC · Traditional | Mdt Corp., Inc. | 12/19/1991SE |
| 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 |
More from Xre Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K960777 | MDT Unispore and Spor-Test BiologicalindicatorFRC · Traditional | 05/23/1996SE |
| K942485 | MDT Urology TableMMZ · Traditional | 08/26/1994SE |
| K942486 | Image Full Power Examination/Minor Surgery TableFQO · Traditional | 08/10/1994SE |
| K924380 | Mdt/Harvey Model 7000 & 8000 ChemiclaveMLR · Traditional | 02/16/1994SE |
| K926081 | Dental LightEAZ · Traditional | 01/26/1994SE |
| K924955 | Mdt/Harvey MC-8 and MC-10FLE · Traditional | 10/15/1993SE |
| K932094 | Bovie Ultrasonic Surgical AspiratorLFL · Traditional | 07/21/1993SE |
| K931169 | MDT Dental ChairKLC · Traditional | 05/20/1993SE |
| K920930 | Mdt/Castle 10/90 Dual Load StationFLF · Traditional | 03/31/1993SE |
| K922212 | MDT Castle Biosign Test PackFRC · Traditional | 08/10/1992SE |
Questions and answers
When was Mdt/Shampaine Model 4900E Surgical Table cleared by the FDA?
Mdt/Shampaine Model 4900E Surgical Table (K915393) received a 510(k) decision of Substantially Equivalent on December 17, 1991, 18 days after the submission was received.
What is the product code of K915393?
The FDA product code is GDC – Table, Operating-Room, Electrical, a Class I (low risk) device regulated under 21 CFR 878.4960.