Gyrex 2T-PRESTIGE
FDA 510(k) K970005 · Elscint, Inc.
510(k) numberK970005
Submission
- Device name
- Gyrex 2T-PRESTIGE
- Applicant
- Elscint, Inc.
Hackensack, NJ, US - Received
- January 2, 1997
- Decision date
- March 28, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K972592 | 2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)MOS · Traditional | 09/15/1997SE |
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| 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 |
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Questions and answers
When was Gyrex 2T-PRESTIGE cleared by the FDA?
Gyrex 2T-PRESTIGE (K970005) received a 510(k) decision of Substantially Equivalent on March 28, 1997, 85 days after the submission was received.
What is the product code of K970005?
The FDA product code is LNI – System, Nuclear Magnetic Resonance Spectroscopic, a Class II (moderate risk) device regulated under 21 CFR 892.1000.