Actiheart
FDA 510(k) K052489 · Respironics, Inc.
510(k) numberK052489
Submission
- Device name
- Actiheart
- Applicant
- Respironics, Inc.
Murrysville, PA, US - Received
- September 12, 2005
- Decision date
- September 27, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was Actiheart cleared by the FDA?
Actiheart (K052489) received a 510(k) decision of Substantially Equivalent on September 27, 2005, 15 days after the submission was received.
What is the product code of K052489?
The FDA product code is GWK – Conditioner, Signal, Physiological, a Class II (moderate risk) device regulated under 21 CFR 882.1845.