Waratah Digital EEG and Sleep Acquisition Devices with, or Without, Pulse Oximetry,Cardinal Digital EEG and Sleep Acquis
FDA 510(k) K990522 · Lamont Medical, Inc.
510(k) numberK990522
Submission
- Device name
- Waratah Digital EEG and Sleep Acquisition Devices with, or Without, Pulse Oximetry,Cardinal Digital EEG and Sleep Acquis
- Applicant
- Lamont Medical, Inc.
Madison, WI, US - Received
- February 18, 1999
- Decision date
- May 19, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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Questions and answers
When was Waratah Digital EEG and Sleep Acquisition Devices with, or Without, Pulse Oximetry,Cardinal Digital EEG and Sleep Acquis cleared by the FDA?
Waratah Digital EEG and Sleep Acquisition Devices with, or Without, Pulse Oximetry,Cardinal Digital EEG and Sleep Acquis (K990522) received a 510(k) decision of Substantially Equivalent on May 19, 1999, 90 days after the submission was received.
What is the product code of K990522?
The FDA product code is OLV – Standard Polysomnograph With Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.