Adel Medical Birthing Bed, Mod. LD-400
FDA 510(k) K801622 · Adel Medical , Ltd.
510(k) numberK801622
Submission
- Device name
- Adel Medical Birthing Bed, Mod. LD-400
- Applicant
- Adel Medical , Ltd.
Mchenry, IL, US - Received
- July 15, 1980
- Decision date
- August 14, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KNC – Table, Obstetric (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4900
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code KNC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K001261 | L720 Examination ChairKNC · Traditional | Luneau Gynecologie SA | 06/08/2000SE |
| K932035 | Non-Linting Delivery BlanketKNC · Traditional | Amsco Sterile Recoveries, Inc. | 05/26/1994SE |
| K924420 | Medical Disposable BeddingKNC · Traditional | Hill-Rom, Inc. | 12/10/1993SE |
| K914544 | BD6000 the Optima & BD5000 Birthing BedKNC · Traditional | Lic Care, Inc. | 11/24/1993SE |
| K915779 | Affinity Bed Model 3600 SeriesKNC · Traditional | Hill-Rom, Inc. | 02/24/1993SE |
| K903973 | Gardosi Birthing CushionKNC · Traditional | Graphic Controls Corp. | 09/27/1990SE |
| K884868 | Obstetrical Safety SystemKNC · Traditional | Buckman Co., Inc. | 03/01/1989SE |
| K870745 | Stryker Model 977 Birthing BedKNC · Traditional | Stryker Corp. | 02/27/1987SE |
| K864194 | Palmer Obstetric BraceKNC · Traditional | Ad-Tech Medical Instrument Corp | 01/14/1987SE |
| K862931 | Merivaara Obstetric Chair/Bed-Model 358KNC · Traditional | Global Medical Prods, Inc. | 08/07/1986SE |
More from Global Medical Prods, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K890476 | Adel - Model 986 Infant WarmerFMZ · Traditional | 06/16/1989SE |
| K874610 | Adel Model 2100 Birthing BedHDD · Traditional | 01/21/1988SE |
| 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 |
Questions and answers
When was Adel Medical Birthing Bed, Mod. LD-400 cleared by the FDA?
Adel Medical Birthing Bed, Mod. LD-400 (K801622) received a 510(k) decision of Substantially Equivalent on August 14, 1980, 30 days after the submission was received.
What is the product code of K801622?
The FDA product code is KNC – Table, Obstetric (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.4900.