Portable Defibrillator/Monitor Ed 425
FDA 510(k) K851092 · Honeywell, Inc.
510(k) numberK851092
Submission
- Device name
- Portable Defibrillator/Monitor Ed 425
- Applicant
- Honeywell, Inc.
Pleasantville, NY, US - Received
- March 19, 1985
- Decision date
- April 10, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LDD – Dc-Defibrillator, Low-Energy, (Including Paddles)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5300
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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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 |
| K834530 | Extension Box EB200DRT · Traditional | 06/01/1984SE |
| K834282 | Ultra Imager 2000IYO · Traditional | 04/23/1984SE |
| K840167 | Portable DefibrillatorLDD · Traditional | 02/04/1984SE |
Questions and answers
When was Portable Defibrillator/Monitor Ed 425 cleared by the FDA?
Portable Defibrillator/Monitor Ed 425 (K851092) received a 510(k) decision of Substantially Equivalent on April 10, 1985, 22 days after the submission was received.
What is the product code of K851092?
The FDA product code is LDD – Dc-Defibrillator, Low-Energy, (Including Paddles), a Class II (moderate risk) device regulated under 21 CFR 870.5300.