Sandman
FDA 510(k) K934599 · Melville Software , Ltd.
510(k) numberK934599
Submission
- Device name
- Sandman
- Applicant
- Melville Software , Ltd.
Ottawa, Ontario, CA - Received
- September 24, 1993
- Decision date
- January 27, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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More from Neurotronics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K943673 | MMC AmplifierGWL · Traditional | 10/26/1994SE |
Questions and answers
When was Sandman cleared by the FDA?
Sandman (K934599) received a 510(k) decision of Substantially Equivalent on January 27, 1994, 125 days after the submission was received.
What is the product code of K934599?
The FDA product code is OLV – Standard Polysomnograph With Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.