T-1000 ECG Transmitter
FDA 510(k) K851124 · Brentwood Instruments, Inc.
510(k) numberK851124
Submission
- Device name
- T-1000 ECG Transmitter
- Applicant
- Brentwood Instruments, Inc.
Torrance, CA, US - Received
- March 19, 1985
- Decision date
- May 15, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXH – Transmitters And Receivers, Electrocardiograph, Telephone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2920
- Specialty
- Cardiovascular
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More from AliveCor, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K896924 | Spiroscan 4000BZG · Traditional | 03/01/1990SE |
| K882366 | Rhythmscan HR Holter RecorderDSH · Traditional | 08/02/1988SE |
| K871572 | RhythmscanDSI · Traditional | 02/22/1988SE |
| K860024 | Fukuda Denshi Cardimax FCP-211DSI · Traditional | 03/31/1986SE |
| K853979 | Cardimax FX-1164DPS · Traditional | 02/06/1986SE |
| K854505 | Cardimax FX-406UDRS · Traditional | 02/04/1986SE |
| K851135 | Spiro ScanBZG · Traditional | 07/01/1985SE |
| K851123 | R-1000 ECG ReceiverDXH · Traditional | 05/15/1985SE |
| K842976 | Brentwood Ez Scan 200 Ambulatory ECGDSI · Traditional | 03/01/1985SE |
| K844470 | Fukuda Denshi Model FCP-220DPS · Traditional | 01/10/1985SE |
Questions and answers
When was T-1000 ECG Transmitter cleared by the FDA?
T-1000 ECG Transmitter (K851124) received a 510(k) decision of Substantially Equivalent on May 15, 1985, 57 days after the submission was received.
What is the product code of K851124?
The FDA product code is DXH – Transmitters And Receivers, Electrocardiograph, Telephone, a Class II (moderate risk) device regulated under 21 CFR 870.2920.