SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes
FDA 510(k) K183574 · Huntleigh Healthcare , Ltd.
510(k) numberK183574
Submission
- Device name
- SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes
- Applicant
- Huntleigh Healthcare , Ltd.
Cardiff, GB - Received
- December 21, 2018
- Decision date
- September 6, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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 SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes cleared by the FDA?
SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes (K183574) received a 510(k) decision of Substantially Equivalent on September 6, 2019, 259 days after the submission was received.
What is the product code of K183574?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.