Ultrasound Equipment Model SDL-100A
FDA 510(k) K837084 · Elscint, Inc.
510(k) numberK837084
Submission
- Device name
- Ultrasound Equipment Model SDL-100A
- Applicant
- Elscint, Inc.
Hackensack, NJ, US - Received
- January 25, 1983
- Decision date
- April 28, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
More from Elscint, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K983313 | Advanced Automatic Detector Selection Option for GloryIZH · Traditional | 12/11/1998SE |
| K982060 | Volumax CT Imaging SystemJAK · Traditional | 09/02/1998SE |
| K974344 | CT ScopeJAK · Traditional | 06/03/1998SE |
| K980306 | Gyrex 2T Prestige, Gyrex Prima Itg, Gyrex Privilege, Gyrex V-EpLNH · Traditional | 04/02/1998SE |
| K974614 | Gyrex 2T Prestige 100-6321-0107, Gyrex Priviledge 100-6326-0102, Gyrex Prima 1TG…LNH · Traditional | 03/04/1998SE |
| K972592 | 2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)MOS · Traditional | 09/15/1997SE |
| K970680 | GloryIZH · Traditional | 06/20/1997SE |
| K965044 | Gyrex 2T Prestige Model No. 100-6321-0107 and Gyrex Privilege Model No. 100-6326-0102LNH · Traditional | 06/16/1997SE |
| K970980 | Cardiac Scoring for CT ScannersJAK · Traditional | 05/29/1997SE |
| K970005 | Gyrex 2T-PRESTIGELNI · Traditional | 03/28/1997SE |
Questions and answers
When was Ultrasound Equipment Model SDL-100A cleared by the FDA?
Ultrasound Equipment Model SDL-100A (K837084) received a 510(k) decision of Substantially Equivalent on April 28, 1983, 93 days after the submission was received.