General Purpose Transducer Standoff, Biopsy Transducer Standoff, Bi-Plane Endocavity Transducer Standoff
FDA 510(k) K992152 · CIVCO Medical Instruments Co., Inc.
510(k) numberK992152
Submission
- Device name
- General Purpose Transducer Standoff, Biopsy Transducer Standoff, Bi-Plane Endocavity Transducer Standoff
- Applicant
- CIVCO Medical Instruments Co., Inc.
Kalona, IA, US - Received
- June 25, 1999
- Decision date
- August 17, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was General Purpose Transducer Standoff, Biopsy Transducer Standoff, Bi-Plane Endocavity Transducer Standoff cleared by the FDA?
General Purpose Transducer Standoff, Biopsy Transducer Standoff, Bi-Plane Endocavity Transducer Standoff (K992152) received a 510(k) decision of Substantially Equivalent on August 17, 1999, 53 days after the submission was received.
What is the product code of K992152?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.