Dopplex Ability
FDA 510(k) K121108 · Huntleigh Healthcare
510(k) numberK121108
Submission
- Device name
- Dopplex Ability
- Applicant
- Huntleigh Healthcare
Cardiff, GB - Received
- April 12, 2012
- Decision date
- January 3, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JOM – Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2780
- Specialty
- Cardiovascular
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Questions and answers
When was Dopplex Ability cleared by the FDA?
Dopplex Ability (K121108) received a 510(k) decision of Substantially Equivalent on January 3, 2013, 266 days after the submission was received.
What is the product code of K121108?
The FDA product code is JOM – Plethysmograph, Photoelectric, Pneumatic Or Hydraulic, a Class II (moderate risk) device regulated under 21 CFR 870.2780.