Am 420 Microprocessor
FDA 510(k) K810163 · Honeywell, Inc.
510(k) numberK810163
Submission
- Device name
- Am 420 Microprocessor
- Applicant
- Honeywell, Inc.
Walker, MI, US - Received
- January 22, 1981
- Decision date
- March 5, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXG – Computer, Diagnostic, Pre-Programmed, Single-Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1435
- Specialty
- Cardiovascular
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| K855125 | Physiological Telemetry Patient Monitoring SystemDRT · Traditional | 03/26/1986SE |
| K851888 | Apm Dispos. Blood Pressure TransducerDRS · Traditional | 08/06/1985SE |
| K851496 | ECG Monitor Model RM102DXJ · Traditional | 07/24/1985SE |
| K850794 | Patient Monitor Model RM-300DTR · Traditional | 04/18/1985SE |
| K851092 | Portable Defibrillator/Monitor Ed 425LDD · Traditional | 04/10/1985SE |
| K834530 | Extension Box EB200DRT · Traditional | 06/01/1984SE |
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Questions and answers
When was Am 420 Microprocessor cleared by the FDA?
Am 420 Microprocessor (K810163) received a 510(k) decision of Substantially Equivalent on March 5, 1981, 42 days after the submission was received.
What is the product code of K810163?
The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.