G.E. Telemetry Monitoring
FDA 510(k) K761259 · General Electric Co.
510(k) numberK761259
Submission
- Device name
- G.E. Telemetry Monitoring
- Applicant
- General Electric Co.
Mchenry, IL, US - Received
- December 15, 1976
- Decision date
- December 21, 1976
- 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 |
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| K072797 | GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE Vivid E Compact…IYO · Special | 10/17/2007SE |
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Questions and answers
When was G.E. Telemetry Monitoring cleared by the FDA?
G.E. Telemetry Monitoring (K761259) received a 510(k) decision of Substantially Equivalent on December 21, 1976, 6 days after the submission was received.
What is the product code of K761259?
The FDA product code is GYE – Encephalogram Telemetry System, a Class II (moderate risk) device regulated under 21 CFR 882.1855.