Nightron Polysomnography System
FDA 510(k) K022249 · Telediagnostic Systems, Inc.
510(k) numberK022249
Submission
- Device name
- Nightron Polysomnography System
- Applicant
- Telediagnostic Systems, Inc.
Redwood City, CA, US - Received
- July 12, 2002
- Decision date
- December 31, 2002
- 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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| K071661 | Alphaone Biofeedback SystemHCC · Traditional | 09/05/2007SE |
| K970659 | DT-24 Telephonic EEG TRANSMITTER/DR-24 Telephonic EEG ReceiverGYE · Traditional | 05/16/1997SE |
| K904328 | Vista Polysomnography Computer SystemGWK · Traditional | 06/18/1991SE |
| K904222 | Vista Graph Polysomnography AmplifierGWL · Traditional | 01/18/1991SE |
| K885328 | RS-10 Telephonic Polysomnography ReceiverGYE · Traditional | 03/22/1989SE |
| K884891 | OC-100 Oximeter Interface CalibratorDQA · Traditional | 12/28/1988SE |
| K883947 | ISO-100 Isolation AmplifierGYE · Traditional | 12/05/1988SE |
| K874257 | S-10 Telephonic PolysomnographGYE · Traditional | 12/11/1987SE |
| K871120 | M10 EEG Monitor ScopeGYE · Traditional | 05/01/1987SE |
| K810872 | EEG Telephone Receiver Model #Afr-JDXH · Traditional | 05/01/1981SE |
Questions and answers
When was Nightron Polysomnography System cleared by the FDA?
Nightron Polysomnography System (K022249) received a 510(k) decision of Substantially Equivalent on December 31, 2002, 172 days after the submission was received.
What is the product code of K022249?
The FDA product code is OLV – Standard Polysomnograph With Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.