Model Afr EEG Telephone Receiver
FDA 510(k) K802657 · Telediagnostic Systems, Inc.
510(k) numberK802657
Submission
- Device name
- Model Afr EEG Telephone Receiver
- Applicant
- Telediagnostic Systems, Inc.
Mchenry, IL, US - Received
- October 24, 1980
- Decision date
- November 12, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code GYE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K963195 | Wireless EEG Recording System Model W32GYE · Traditional | Cme Telemetrix, Inc. | 07/29/1997SE |
| K970659 | DT-24 Telephonic EEG TRANSMITTER/DR-24 Telephonic EEG ReceiverGYE · Traditional | Telediagnostic Systems, Inc. | 05/16/1997SE |
| K895895 | Model 219 Telemetry SystemGYE · Traditional | Mennen Medical, Inc. | 02/22/1990SE |
| K891405 | BMS-2000 Mobile EEG SystemGYE · Traditional | Buckman Co., Inc. | 08/02/1989SE |
| K885328 | RS-10 Telephonic Polysomnography ReceiverGYE · Traditional | Telediagnostic Systems, Inc. | 03/22/1989SE |
| K883947 | ISO-100 Isolation AmplifierGYE · Traditional | Telediagnostic Systems, Inc. | 12/05/1988SE |
| K883461 | Dad 16S, Data Acquistion Device 16 Ch. SeriesGYE · Traditional | Biohm, Inc. | 11/30/1988SE |
| K874257 | S-10 Telephonic PolysomnographGYE · Traditional | Telediagnostic Systems, Inc. | 12/11/1987SE |
| K871120 | M10 EEG Monitor ScopeGYE · Traditional | Telediagnostic Systems, Inc. | 05/01/1987SE |
| K860128 | Modac-Xxxx Intensive Monitoring of EEGGYE · Traditional | Grass-Telefactor Product Group | 03/27/1986SE |
More from Grass-Telefactor Product Group
| 510(k) | Device | Decision |
|---|---|---|
| K071661 | Alphaone Biofeedback SystemHCC · Traditional | 09/05/2007SE |
| K022249 | Nightron Polysomnography SystemOLV · Traditional | 12/31/2002SE |
| 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 |
Questions and answers
When was Model Afr EEG Telephone Receiver cleared by the FDA?
Model Afr EEG Telephone Receiver (K802657) received a 510(k) decision of Substantially Equivalent on November 12, 1980, 19 days after the submission was received.
What is the product code of K802657?
The FDA product code is GYE – Encephalogram Telemetry System, a Class II (moderate risk) device regulated under 21 CFR 882.1855.