Adel Model 2100 Birthing Bed
FDA 510(k) K874610 · Adel Medical , Ltd.
510(k) numberK874610
Submission
- Device name
- Adel Model 2100 Birthing Bed
- Applicant
- Adel Medical , Ltd.
Clackamas, OR, US - Received
- November 9, 1987
- Decision date
- January 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 |
| K875123 | OrcepadHDD · Traditional | Alton Dean Medical, Inc. | 06/21/1988SE |
| 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 |
More from I E Industries
| 510(k) | Device | Decision |
|---|---|---|
| K890476 | Adel - Model 986 Infant WarmerFMZ · Traditional | 06/16/1989SE |
| K871475 | Sololift - Patient Transfer StretcherFMR · Traditional | 05/11/1987SE |
| K861030 | Labor-Delivery Stretch/BedKNC · Traditional | 04/23/1986SE |
| K860020 | Minor Surgery Light Model 2112FSS · Traditional | 01/24/1986SE |
| K833321 | Labor/Delivery/Recovery Bed LDR-600KNC · Traditional | 11/14/1983SE |
| K810886 | Adel Medical Birthing Bed, #LD-500HDD · Traditional | 04/23/1981SE |
| K801622 | Adel Medical Birthing Bed, Mod. LD-400KNC · Traditional | 08/14/1980SE |
Questions and answers
When was Adel Model 2100 Birthing Bed cleared by the FDA?
Adel Model 2100 Birthing Bed (K874610) received a 510(k) decision of Substantially Equivalent on January 21, 1988, 73 days after the submission was received.
What is the product code of K874610?
The FDA product code is HDD – Table, Obstetrical, Ac-Powered (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.4900.