OP3/VP4
FDA 510(k) K924516 · Huntleigh Technology, Inc.
510(k) numberK924516
Submission
- Device name
- OP3/VP4
- Applicant
- Huntleigh Technology, Inc.
Manalapan, NJ, US - Received
- September 4, 1992
- Decision date
- June 28, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HGL – Transducer, Ultrasonic, Obstetric
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2960
- Specialty
- Obstetrics/Gynecology
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| 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 |
| 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 |
| K900838 | Transvaginal Transducer AssemblyHGL · Traditional | Pie Medical Equipment B.V. | 05/23/1990SE |
| 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 |
|---|---|---|
| K992733 | Akron ATP9 Traction MachineITH · Traditional | 11/10/1999SE |
| K964699 | Rheo Dopplex II (RD 2)IYN · Traditional | 02/21/1997SE |
| K910188 | Flowplus AC330 Pump GarmentsJOW · Traditional | 05/28/1991SE |
| K900882 | Multi Dopplex, MD-1JAF · Traditional | 08/22/1990SE |
| K900618 | Huntleigh Fetal Doppler, FD-1 & Dopcord, D140KNG · Traditional | 04/25/1990SE |
| K890012 | Huntleigh Dynamic Flotation SystemFNM · Traditional | 03/29/1989SE |
| K884451 | Dopcord PPGJOM · Traditional | 01/12/1989SE |
| K881632 | Flowtron DVT System AC500 Pump, L501 GarmentJOW · Traditional | 09/26/1988SE |
| K874688 | Flowtron AC200/2IRP · Traditional | 09/23/1988SE |
| K882644 | Huntleigh Double Bubble AIR-O-PAD-AOP5FNM · Traditional | 08/10/1988SE |
Questions and answers
When was OP3/VP4 cleared by the FDA?
OP3/VP4 (K924516) received a 510(k) decision of Substantially Equivalent on June 28, 1993, 297 days after the submission was received.
What is the product code of K924516?
The FDA product code is HGL – Transducer, Ultrasonic, Obstetric, a Class II (moderate risk) device regulated under 21 CFR 884.2960.