Aloka UST-5514DTU-7.5 Linear Doppler Transducer
FDA 510(k) K901335 · Ge Medical Systems Information Technologies
510(k) numberK901335
Submission
- Device name
- Aloka UST-5514DTU-7.5 Linear Doppler Transducer
- Applicant
- Ge Medical Systems Information Technologies
Wallingford, CT, US - Received
- March 22, 1990
- Decision date
- August 10, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DPW – Flowmeter, Blood, Cardiovascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2100
- Specialty
- Cardiovascular
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Questions and answers
When was Aloka UST-5514DTU-7.5 Linear Doppler Transducer cleared by the FDA?
Aloka UST-5514DTU-7.5 Linear Doppler Transducer (K901335) received a 510(k) decision of Substantially Equivalent on August 10, 1990, 141 days after the submission was received.
What is the product code of K901335?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.