Table, Obstetrical, Ac-Powered (And Accessories)
The AC-Powered Obstetrical Table and Accessories is an electrically powered patient positioning table designed for labor, delivery, and gynecological procedures, with adjustable sections and accessory attachments to support obstetrical care. It is classified as a Class 2 device (moderate risk). The product code is HDD under regulation 21 CFR 884.4900 in the Obstetrics/Gynecology specialty. No implant, life-sustaining, GMP exempt, or third-party review flags apply.
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Basic Information
- Product Code
- HDD
- Device Class
- FDA class 2
- Regulation Number
- 884.4900
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K950889 | ADEL 5000 | Oct 16, 1995 | Substantially Equivalent | Stryker Corp. |
| K914309 | THE GENESIS BED FROM HILL-ROM, MODEL 355 SERIES | Apr 20, 1992 | Substantially Equivalent | Hill-Rom, Inc. |
| K875123 | ORCEPAD | Jun 21, 1988 | Substantially Equivalent | Alton Dean Medical, Inc. |
| K874610 | ADEL MODEL 2100 BIRTHING BED | Jan 21, 1988 | Substantially Equivalent | Adel Medical , Ltd. |
| K810886 | ADEL MEDICAL BIRTHING BED, #LD-500 | Apr 23, 1981 | Substantially Equivalent | Adel Medical , Ltd. |
| K771942 | TILT 10, CATALOG #S-2600 | Oct 27, 1977 | Substantially Equivalent | Affiliated Hospital Products, Inc. |
| K770438 | CART, PROCEDURES | Jul 01, 1977 | Substantially Equivalent | I E Industries |
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.