Extended Measurements System
FDA 510(k) K051450 · Inovise Medical, Inc.
510(k) numberK051450
Submission
- Device name
- Extended Measurements System
- Applicant
- Inovise Medical, Inc.
Portland, OR, US - Received
- June 2, 2005
- Decision date
- November 10, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQD – Stethoscope, Electronic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1875
- Specialty
- Cardiovascular
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Questions and answers
When was Extended Measurements System cleared by the FDA?
Extended Measurements System (K051450) received a 510(k) decision of Substantially Equivalent on November 10, 2005, 161 days after the submission was received.
What is the product code of K051450?
The FDA product code is DQD – Stethoscope, Electronic, a Class II (moderate risk) device regulated under 21 CFR 870.1875.