Orcepad
FDA 510(k) K875123 · Alton Dean Medical, Inc.
510(k) numberK875123
Submission
- Device name
- Orcepad
- Applicant
- Alton Dean Medical, Inc.
North Salt Lake City, UT, US - Received
- December 15, 1987
- Decision date
- June 21, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
Other 510(k)s with product code HDD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K950889 | Adel 5000HDD · Traditional | Stryker Corp. | 10/16/1995SE |
| K914309 | The Genesis Bed From Hill-Rom, Model 355 SeriesHDD · Traditional | Hill-Rom, Inc. | 04/20/1992SE |
| 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 |
Questions and answers
When was Orcepad cleared by the FDA?
Orcepad (K875123) received a 510(k) decision of Substantially Equivalent on June 21, 1988, 189 days after the submission was received.
What is the product code of K875123?
The FDA product code is HDD – Table, Obstetrical, Ac-Powered (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.4900.