Luna
FDA 510(k) K982351 · Stellate Systems
510(k) numberK982351
Submission
- Device name
- Luna
- Applicant
- Stellate Systems
Canada, H32 2n2, CA - Received
- July 6, 1998
- Decision date
- July 29, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- OLT – Non-Normalizing Quantitative Electroencephalograph Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user.
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|---|---|---|---|
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| K191322 | E-Eegx, N-EegxOLT · Traditional | GE Healthcare Finland Oy | 01/22/2020SE |
| K192572 | CNS EnvisionOLT · Traditional | Moberg Research, Inc. | 12/17/2019SE |
| K190760 | Cadwell Bolt SoftwareOLT · Traditional | Cadwell Industries, Inc. | 11/23/2019SE |
More from Cadwell Industries, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K083577 | Harmonie SystemGWQ · Abbreviated | 08/29/2011SE |
| K013450 | Notta Ambulatory RecorderOLV · Abbreviated | 01/14/2002SE |
| K010728 | Harmone-Schwarzer EEG SystemOLV · Abbreviated | 05/21/2001SE |
| K955577 | Eclipse Version 3.0OLT · Traditional | 09/20/1996SE |
| K960273 | Harmonie SensaOMB · Traditional | 04/04/1996SE |
| K912938 | RhythmGWS · Traditional | 07/30/1991SE |
Questions and answers
When was Luna cleared by the FDA?
Luna (K982351) received a 510(k) decision of Substantially Equivalent on July 29, 1998, 23 days after the submission was received.
What is the product code of K982351?
The FDA product code is OLT – Non-Normalizing Quantitative Electroencephalograph Software, a Class II (moderate risk) device regulated under 21 CFR 882.1400.