D.C. Amplifier Module
FDA 510(k) K770247 · Mennen Greatbatch Electonics
510(k) numberK770247
Submission
- Device name
- D.C. Amplifier Module
- Applicant
- Mennen Greatbatch Electonics
Mchenry, IL, US - Received
- February 7, 1977
- Decision date
- February 14, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRQ – Amplifier And Signal Conditioner, Transducer Signal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2060
- Specialty
- Cardiovascular
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| K913875 | Bard(R) Biopotential Amplifier IIDRQ · Traditional | Bard Electrophysiology | 11/27/1991SE |
More from Bard Electrophysiology
| 510(k) | Device | Decision |
|---|---|---|
| K772000 | ECG Telemetry SystemDRG · Traditional | 11/22/1977SE |
| K770832 | Portascope IIDPS · Traditional | 06/03/1977SE |
| K770279 | Monitor, Portable, Part #431-010DXJ · Traditional | 02/24/1977SE |
| K770246 | Isolated EEG Amplifier ModuleGWQ · Traditional | 02/14/1977SE |
| K770245 | Abdominal Fetal ECG ModuleKXN · Traditional | 02/14/1977SE |
Questions and answers
When was D.C. Amplifier Module cleared by the FDA?
D.C. Amplifier Module (K770247) received a 510(k) decision of Substantially Equivalent on February 14, 1977, 7 days after the submission was received.
What is the product code of K770247?
The FDA product code is DRQ – Amplifier And Signal Conditioner, Transducer Signal, a Class II (moderate risk) device regulated under 21 CFR 870.2060.