Fetal Doppler for Ultramark 4 and 8
FDA 510(k) K881329 · Advanced Technology Laboratories, Inc.
510(k) numberK881329
Submission
- Device name
- Fetal Doppler for Ultramark 4 and 8
- Applicant
- Advanced Technology Laboratories, Inc.
Bothell, WA, US - Received
- March 30, 1988
- Decision date
- April 14, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HEM – Imager, Ultrasonic Obstetric-Gynecologic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2225
- Specialty
- Obstetrics/Gynecology
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|---|---|---|---|
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| K942490 | Babe Computer Pogram for Obstetric UltrasoundHEM · Traditional | Medical Soft, Inc. | 02/15/1995SE |
| K910426 | Sdu 500 Diagnostic Ultrasound InstrumentHEM · Traditional | Shimadzu Medical Systems | 06/06/1991SE |
| K905000 | Aloka UST-964P-5 Endovaginal TransducerHEM · Traditional | Corometrics Medical Systems, Inc. | 01/31/1991SE |
| K900505 | Sonoace 88 Portable Ultrasound ScannerHEM · Traditional | Medison Co., Ltd. | 08/10/1990SE |
| K900271 | Model OB-500 Fetal Growth Analysis & Option OblinkHEM · Traditional | Digisonics, Inc. | 04/19/1990SE |
| K890637 | Extended Obstetrics Software Computation PackageHEM · Traditional | Elscint, Inc. | 06/12/1989SE |
| K885061 | Siemens Intravaginal TransducerHEM · Traditional | Siemens Medical Solutions USA, Inc. | 02/23/1989SE |
| K881185 | Annular Array Probes for Artis 3200 Diag. Ultra.HEM · Traditional | Philips Medical Systems (Cleveland), Inc. | 06/01/1988SE |
| K880900 | SSD-620 Linear/Convex Array Sector ScannerHEM · Traditional | Corometrics Medical Systems, Inc. | 06/01/1988SE |
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| K002144 | Medlink Diagnostic Offline WorkstationLLZ · Traditional | 09/28/2000SE |
| K992470 | Ultramark 400C/SONOACE 6000 Ultrasound SystemIYO · Traditional | 08/23/1999SE |
| K991671 | Hdi 5000 Diagnostic Ultrasound SystemIYO · Traditional | 06/18/1999SE |
| K961459 | Level 10 HdiIYO · Traditional | 03/26/1997SE |
| K935009 | PegasusIYN · Traditional | 10/11/1994SE |
| K940423 | Nova Microsonics Access Image Management Network/Access Acquisition ModuleLMD · Traditional | 07/29/1994SE |
| K905248 | Nova Microsonics Capricorn Digital Image SystemsDQK · Traditional | 02/28/1991SE |
| K903603 | Ultramark 9 Ultrasound System (Um 9)IYO · Traditional | 02/26/1991SE |
Questions and answers
When was Fetal Doppler for Ultramark 4 and 8 cleared by the FDA?
Fetal Doppler for Ultramark 4 and 8 (K881329) received a 510(k) decision of Substantially Equivalent on April 14, 1989, 380 days after the submission was received.
What is the product code of K881329?
The FDA product code is HEM – Imager, Ultrasonic Obstetric-Gynecologic, a Class II (moderate risk) device regulated under 21 CFR 884.2225.