Blood Pressure, Digital Model #2153
FDA 510(k) K781701 · Sears, Roebuck & Co.
510(k) numberK781701
Submission
- Device name
- Blood Pressure, Digital Model #2153
- Applicant
- Sears, Roebuck & Co.
Mchenry, IL, US - Received
- October 10, 1978
- Decision date
- December 4, 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
Other 510(k)s with product code DSK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K810635 | Electrode Blood Pressure MonitorDSK · Traditional | 05/08/1981SE |
| K800778 | Digital Electronic B.P. Monitor 2155DXN · Traditional | 04/29/1980SE |
| K800072 | Digital Electronic Exerciser/Pulse Mtr.ISD · Traditional | 01/28/1980SE |
| K780986 | Digital Blood Pressure MonitorDXN · Traditional | 07/18/1978SE |
| K771666 | Sphygmomanometer #1235DXG · Traditional | 09/30/1977SE |
Questions and answers
When was Blood Pressure, Digital Model #2153 cleared by the FDA?
Blood Pressure, Digital Model #2153 (K781701) received a 510(k) decision of Substantially Equivalent on December 4, 1978, 55 days after the submission was received.
What is the product code of K781701?
The FDA product code is DSK – Computer, Blood-Pressure, a Class II (moderate risk) device regulated under 21 CFR 870.1110.