Interspec Apogee RX400 Ultrasound Imaging System and Doppler Ultrasound Flowmeter
FDA 510(k) K940671 · Interspec, Inc.
510(k) numberK940671
Submission
- Device name
- Interspec Apogee RX400 Ultrasound Imaging System and Doppler Ultrasound Flowmeter
- Applicant
- Interspec, Inc.
Ambler, PA, US - Received
- February 16, 1994
- Decision date
- November 22, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Interspec Apogee RX400 Ultrasound Imaging System and Doppler Ultrasound Flowmeter cleared by the FDA?
Interspec Apogee RX400 Ultrasound Imaging System and Doppler Ultrasound Flowmeter (K940671) received a 510(k) decision of Substantially Equivalent on November 22, 1994, 279 days after the submission was received.
What is the product code of K940671?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.