OLTClass II
Non-Normalizing Quantitative Electroencephalograph Software
21 CFR 882.1400 / Neurology
OLT is the FDA product code for Non-Normalizing Quantitative Electroencephalograph Software, a class II device type, regulated under 21 CFR 882.1400. FDA's definition for this code reads: "Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user". As of , FDA records hold 56 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- OLT
- Device name
- Non-Normalizing Quantitative Electroencephalograph Software
- FDA definition
- Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user.
- Regulation
- 21 CFR 882.1400
- Device class
- Class II
- Review panel
- Neurology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 57
- Ingested recalls
- 0
Clearances, product code OLT
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1981 | 1 |
| 1982 | 1 |
| 1984 | 2 |
| 1985 | 2 |
| 1986 | 3 |
| 1987 | 1 |
| 1988 | 1 |
| 1989 | 2 |
| 1991 | 1 |
| 1992 | 1 |
| 1994 | 1 |
| 1995 | 4 |
| 1996 | 3 |
| 1998 | 1 |
| 1999 | 1 |
| 2000 | 4 |
| 2003 | 3 |
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 2 |
| 2009 | 2 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 5 |
| 2019 | 2 |
| 2020 | 1 |
| 2022 | 2 |
| 2024 | 1 |
| 2025 | 2 |
| 2026 | 3 |
Applicants with the most clearances
Product code OLT| Applicant | Clearances |
|---|---|
| Aspect Medical Systems, Inc. | 2 |
| Brainz Instruments, Ltd. | 2 |
| GE Healthcare | 2 |
| Infinite Biomedical Technologies, LLC | 2 |
| Kvikna Ehf | 2 |
| Medelec, Ltd. | 2 |
| Neuro Scan Labs | 2 |
| Neurosoft Ltd | 2 |
| Stellate Systems | 2 |
| Teca, Inc. | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Ait Austrian Institute of Technology GmbH
- Amphenol Cable and Interconnect Technologies Asia Pacific Ltd.
- Amphenol Medical Technologies (Dongguan) Co., Ltd.
- Burak Global IC ve Dis Tic Ltd Sti
- Cadwell Industries Inc
- Change Healthcare Canada Company
- Datascope Corp.
- DHL Supply Chain (Netherlands) B.V.
- Diversatek Healthcare Inc
- Draeger Medical Systems, Inc.
- Ducommun LaBarge Technologies
- EB Neuro S.p.A.
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