HHP · Table, Obstetrical, Manual (And Accessories)
Obstetrics/Gynecology · 21 CFR 884.4900 · Class 2
Overview
| Product Code | HHP |
|---|---|
| Device Name | Table, Obstetrical, Manual (And Accessories) |
| Regulation | 21 CFR 884.4900 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
Identification
An obstetric table is a device with adjustable sections designed to support a patient in the various positions required during obstetric and gynecologic procedures. This generic type of device may include the following accessories: patient equipment, support attachments, and cabinets for warming instruments and disposing of wastes.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K963505 | TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEM | Tenet Medical Engineering | Feb 14, 1997 | SESE |
| K822812 | YSI MODEL 23L LACTATE ANALYZER | Yellow Springs Instrument Co., Inc. | Dec 13, 1982 | SESE |
Top Applicants
- Yellow Springs Instrument Co., Inc. — 1 clearance
- Tenet Medical Engineering — 1 clearance
