GE Medical-Needle Guide for SV, TR Andatf, Acuson-Needle Guide
FDA 510(k) K971115 · Protek Medical Products, Inc.
510(k) numberK971115
Submission
- Device name
- GE Medical-Needle Guide for SV, TR Andatf, Acuson-Needle Guide
- Applicant
- Protek Medical Products, Inc.
Iowa City, IA, US - Received
- March 27, 1997
- Decision date
- June 13, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K970889 | Ultrasound Transducer DrapeKKX · Traditional | 10/20/1997SE |
| K973362 | Needle Guide/GridITX · Traditional | 10/01/1997SE |
| K970885 | Ultrasound Systems DrapeMMP · Traditional | 09/22/1997SE |
| K970891 | Drape, Surgical-LatexKKX · Traditional | 08/22/1997SE |
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Questions and answers
When was GE Medical-Needle Guide for SV, TR Andatf, Acuson-Needle Guide cleared by the FDA?
GE Medical-Needle Guide for SV, TR Andatf, Acuson-Needle Guide (K971115) received a 510(k) decision of Substantially Equivalent on June 13, 1997, 78 days after the submission was received.
What is the product code of K971115?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.