Adel 5000
FDA 510(k) K950889 · Stryker Corp.
510(k) numberK950889
Submission
- Device name
- Adel 5000
- Applicant
- Stryker Corp.
Kalamazoo, MI, US - Received
- February 28, 1995
- Decision date
- October 16, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HDD – Table, Obstetrical, Ac-Powered (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4900
- Specialty
- Obstetrics/Gynecology
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|---|---|---|---|
| K914309 | The Genesis Bed From Hill-Rom, Model 355 SeriesHDD · Traditional | Hill-Rom, Inc. | 04/20/1992SE |
| K875123 | OrcepadHDD · Traditional | Alton Dean Medical, Inc. | 06/21/1988SE |
| K874610 | Adel Model 2100 Birthing BedHDD · Traditional | Adel Medical , Ltd. | 01/21/1988SE |
| K810886 | Adel Medical Birthing Bed, #LD-500HDD · Traditional | Adel Medical , Ltd. | 04/23/1981SE |
| K771942 | Tilt 10, Catalog #S-2600HDD · Traditional | Affiliated Hospital Products, Inc. | 10/27/1977SE |
| K770438 | Cart, ProceduresHDD · Traditional | I E Industries | 07/01/1977SE |
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Questions and answers
When was Adel 5000 cleared by the FDA?
Adel 5000 (K950889) received a 510(k) decision of Substantially Equivalent on October 16, 1995, 230 days after the submission was received.
What is the product code of K950889?
The FDA product code is HDD – Table, Obstetrical, Ac-Powered (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.4900.