STN Probe
FDA 510(k) K101816 · Summit Doppler Systems, Inc.
510(k) numberK101816
Submission
- Device name
- STN Probe
- Applicant
- Summit Doppler Systems, Inc.
Golden, CO, US - Received
- June 30, 2010
- Decision date
- August 19, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K060410 | Echoheart Transvaginal Doppler ProbeHEK · Traditional | 04/10/2006SE |
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Questions and answers
When was STN Probe cleared by the FDA?
STN Probe (K101816) received a 510(k) decision of Substantially Equivalent on August 19, 2010, 50 days after the submission was received.
What is the product code of K101816?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.