Sasssy Semi Automatic Sleep Scoring System
FDA 510(k) K860219 · Grass-Telefactor Product Group
510(k) numberK860219
Submission
- Device name
- Sasssy Semi Automatic Sleep Scoring System
- Applicant
- Grass-Telefactor Product Group
W. Conshohocken, PA, US - Received
- January 22, 1986
- Decision date
- April 17, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Sasssy Semi Automatic Sleep Scoring System cleared by the FDA?
Sasssy Semi Automatic Sleep Scoring System (K860219) received a 510(k) decision of Substantially Equivalent on April 17, 1986, 85 days after the submission was received.
What is the product code of K860219?
The FDA product code is OLV – Standard Polysomnograph With Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.