Dual Trace Patient Monitor 116,118,120
FDA 510(k) K810179 · Honeywell, Inc.
510(k) numberK810179
Submission
- Device name
- Dual Trace Patient Monitor 116,118,120
- Applicant
- Honeywell, Inc.
Mchenry, IL, US - Received
- January 22, 1981
- Decision date
- February 25, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DSK – Computer, Blood-Pressure
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1110
- Specialty
- Cardiovascular
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| K011865 | Zoll M Series Ibp Operation; Zoll M Series Temperature OptionDSK · Traditional | Zoll Medical Corp | 07/31/2001SE |
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| 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 |
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Questions and answers
When was Dual Trace Patient Monitor 116,118,120 cleared by the FDA?
Dual Trace Patient Monitor 116,118,120 (K810179) received a 510(k) decision of Substantially Equivalent on February 25, 1981, 34 days after the submission was received.
What is the product code of K810179?
The FDA product code is DSK – Computer, Blood-Pressure, a Class II (moderate risk) device regulated under 21 CFR 870.1110.