SSD-620 Linear/Convex Array Sector Scanner
FDA 510(k) K880900 · Corometrics Medical Systems, Inc.
510(k) numberK880900
Submission
- Device name
- SSD-620 Linear/Convex Array Sector Scanner
- Applicant
- Corometrics Medical Systems, Inc.
Wallingford, CT, US - Received
- March 2, 1988
- Decision date
- June 1, 1988
- 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 |
| K881329 | Fetal Doppler for Ultramark 4 and 8HEM · Traditional | Advanced Technology Laboratories, Inc. | 04/14/1989SE |
| 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 |
More from Philips Medical Systems (Cleveland), Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K982651 | Corometrics Model 5700 and 2264 Watertight TransducerHEL · Traditional | 12/11/1998SE |
| K905000 | Aloka UST-964P-5 Endovaginal TransducerHEM · Traditional | 01/31/1991SE |
| K903623 | MODEL600 Uterine Activity MonitorHFM · Traditional | 11/07/1990SE |
| K891997 | Catalog #2270AAX, 2270DAX Beltless TocotransducerHFM · Traditional | 06/08/1989SE |
Questions and answers
When was SSD-620 Linear/Convex Array Sector Scanner cleared by the FDA?
SSD-620 Linear/Convex Array Sector Scanner (K880900) received a 510(k) decision of Substantially Equivalent on June 1, 1988, 91 days after the submission was received.
What is the product code of K880900?
The FDA product code is HEM – Imager, Ultrasonic Obstetric-Gynecologic, a Class II (moderate risk) device regulated under 21 CFR 884.2225.