Transvaginal Transducer Assembly
FDA 510(k) K900838 · Pie Medical Equipment B.V.
510(k) numberK900838
Submission
- Device name
- Transvaginal Transducer Assembly
- Applicant
- Pie Medical Equipment B.V.
Maastricht, NL - Received
- February 22, 1990
- Decision date
- May 23, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HGL – Transducer, Ultrasonic, Obstetric
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2960
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HGL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K952031 | Ultrasound Transducer, Model US917HGL · Traditional | Advanced Medical Systems, Inc. | 07/18/1995SE |
| K923335 | Ultrasound Transucer, Model US915 -- ModificationHGL · Traditional | Advanced Medical Systems, Inc. | 07/22/1994SE |
| K924516 | OP3/VP4HGL · Traditional | Huntleigh Technology, Inc. | 06/28/1993SE |
| K903348 | Ultrasonic Pulsed Doppler Imaging SystemHGL · Traditional | Advanced Technology Laboratories, Inc. | 10/22/1990SE |
| K900966 | EUP-V12 5.0 MHZ Convex Array Transvaginal ProbeHGL · Traditional | Hitachi Medical Corp. of America | 09/12/1990SE |
| K903316 | Aloka UST-964P-5 Endovaginal TransducerHGL · Traditional | Ge Medical Systems Information Technologies | 08/22/1990SE |
| K901142 | Mer Multiplane Vaginal Probe (MVP)HGL · Traditional | Medical Equipment Resources | 08/22/1990SE |
| K895449 | Aloka Model SSD-650 Ultrasound Imaging SystemHGL · Traditional | Ge Medical Systems Information Technologies | 03/05/1990SE |
| K881263 | Model 500A Vascular Spectrum Analyzer W/DopplerHGL · Traditional | Multigon Industries, Inc. | 01/05/1990SE |
| K895647 | 5.0 MHZ Convex Array Intravaginal TransducerHGL · Traditional | Advanced Technology Laboratories, Inc. | 12/18/1989SE |
More from Advanced Technology Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K982203 | Caas II Lva Biplane OptionIZI · Traditional | 07/14/1998SE |
| K945540 | Caas IIIZI · Traditional | 06/28/1995SE |
| K915647 | Diagnostic Ultrasound System Model SC250ITX · Traditional | 11/09/1992SE |
| K912819 | SC1150 Cw/PdIYN · Traditional | 01/09/1992SE |
| K911584 | Diagnostic Ultrasound System Model SC480IYO · Traditional | 10/24/1991SE |
| K911043 | Hemisphere Multiplane Endorectal ProbeITX · Traditional | 10/09/1991SE |
| K911044 | 7.5 MHZ Apas Transducer (Art.Nol: 50.04918.1)ITX · Traditional | 10/07/1991SE |
Questions and answers
When was Transvaginal Transducer Assembly cleared by the FDA?
Transvaginal Transducer Assembly (K900838) received a 510(k) decision of Substantially Equivalent on May 23, 1990, 90 days after the submission was received.
What is the product code of K900838?
The FDA product code is HGL – Transducer, Ultrasonic, Obstetric, a Class II (moderate risk) device regulated under 21 CFR 884.2960.