Dinamap Model 846
FDA 510(k) K781053 · Applied Medical Research
510(k) numberK781053
Submission
- Device name
- Dinamap Model 846
- Applicant
- Applied Medical Research
Mchenry, IL, US - Received
- June 22, 1978
- Decision date
- September 7, 1978
- 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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|---|---|---|---|
| K231586 | Endophys Blood Pressure Monitor model BPM-30DSK · Traditional | Endophys Technologies, LLC | 11/03/2023SE |
| K160945 | Endophys Blood Pressure MonitorDSK · Traditional | Endophys Holdings, LLC | 09/26/2016SE |
| K152582 | CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter BoxDSK · Special | Volcano Corporation | 12/03/2015SE |
| K141615 | Endophys Blood Pressure MonitorDSK · Traditional | Endophys, Inc. | 01/07/2015SE |
| K080670 | Modification to Sphygmocor Cardiovascular Management SystemDSK · Special | Atcor Medical | 04/23/2008SE |
| K070795 | Sphygmocor Cardiovascular Management SystemDSK · Traditional | Atcor Medical Pty, Ltd. | 08/31/2007SE |
| K033738 | Monitoring System, Model Argus PB-2200DSK · Traditional | Schiller AG | 08/24/2004SE |
| K021517 | Abp for WindowsDSK · Traditional | Rozinn Electronics, Inc. | 07/24/2002SE |
| K013943 | Radianalyzer, Model 12710, Radiview (Pc-Software Accessory), Model 12720DSK · Special | Radi Medical Systems AB | 12/18/2001SE |
| K011865 | Zoll M Series Ibp Operation; Zoll M Series Temperature OptionDSK · Traditional | Zoll Medical Corp | 07/31/2001SE |
More from Zoll Medical Corp
| 510(k) | Device | Decision |
|---|---|---|
| K800025 | Dinamap Research Monitor 1245DXN · Traditional | 02/01/1980SE |
| K791580 | Cerebral Function Monitor 870OMA · Traditional | 09/04/1979SE |
| K791159 | Dinamap Model 855DXN · Traditional | 07/30/1979SE |
| K790322 | Optional Accessory Foot Switch Model 100EBW · Traditional | 05/14/1979SE |
| K790328 | Model 1051, MonitorDXN · Traditional | 03/02/1979SE |
| K782073 | Dinamap Models 1160 and 1165DSK · Traditional | 02/23/1979SE |
| K781064 | Dinamap Model 848DSK · Traditional | 09/07/1978SE |
| K781311 | Electrode, Needle, CFMGXZ · Traditional | 08/21/1978SE |
| K780754 | Neonatal MonitorDXN · Traditional | 06/14/1978SE |
| K780759 | Model 902 StandFSH · Traditional | 05/19/1978SE |
Questions and answers
When was Dinamap Model 846 cleared by the FDA?
Dinamap Model 846 (K781053) received a 510(k) decision of Substantially Equivalent on September 7, 1978, 77 days after the submission was received.
What is the product code of K781053?
The FDA product code is DSK – Computer, Blood-Pressure, a Class II (moderate risk) device regulated under 21 CFR 870.1110.