Falcon HST
FDA 510(k) K242447 · Compumedics Limited
510(k) numberK242447
Submission
- Device name
- Falcon HST
- Applicant
- Compumedics Limited
Abbotsford, AU - Received
- August 16, 2024
- Decision date
- February 20, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- OLV – Standard Polysomnograph With Electroencephalograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
Acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and/or oximetry signals) for sleep recordings. May also be used to allow on-screen review, user-controlled annotation and user-controlled marking of data.
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Questions and answers
When was Falcon HST cleared by the FDA?
Falcon HST (K242447) received a 510(k) decision of Substantially Equivalent on February 20, 2025, 188 days after the submission was received.
What is the product code of K242447?
The FDA product code is OLV – Standard Polysomnograph With Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.