ECG Monitor Model RM102
FDA 510(k) K851496 · Honeywell, Inc.
510(k) numberK851496
Submission
- Device name
- ECG Monitor Model RM102
- Applicant
- Honeywell, Inc.
Pleasantville, NY, US - Received
- April 15, 1985
- Decision date
- July 24, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXJ – Display, Cathode-Ray Tube, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2450
- Specialty
- Cardiovascular
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| 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 ECG Monitor Model RM102 cleared by the FDA?
ECG Monitor Model RM102 (K851496) received a 510(k) decision of Substantially Equivalent on July 24, 1985, 100 days after the submission was received.
What is the product code of K851496?
The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.