Rhythmscan HR Holter Recorder
FDA 510(k) K882366 · Brentwood Instruments, Inc.
510(k) numberK882366
Submission
- Device name
- Rhythmscan HR Holter Recorder
- Applicant
- Brentwood Instruments, Inc.
Torrange, CA, US - Received
- June 8, 1988
- Decision date
- August 2, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DSH – Recorder, Magnetic Tape, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2800
- Specialty
- Cardiovascular
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More from Bardy Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K896924 | Spiroscan 4000BZG · Traditional | 03/01/1990SE |
| 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 |
| K851124 | T-1000 ECG TransmitterDXH · Traditional | 05/15/1985SE |
| 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 Rhythmscan HR Holter Recorder cleared by the FDA?
Rhythmscan HR Holter Recorder (K882366) received a 510(k) decision of Substantially Equivalent on August 2, 1988, 55 days after the submission was received.
What is the product code of K882366?
The FDA product code is DSH – Recorder, Magnetic Tape, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2800.