Local Report Generator
FDA 510(k) K904318 · Spacelabs, Inc.
510(k) numberK904318
Submission
- Device name
- Local Report Generator
- Applicant
- Spacelabs, Inc.
Redmond, WA, US - Received
- September 20, 1990
- Decision date
- December 18, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXN – System, Measurement, Blood-Pressure, Non-Invasive
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1130
- Specialty
- Cardiovascular
Other 510(k)s with product code DXN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261929 | Upper Arm Blood pressure monitor (BP7155D)DXN · Special | OMRON Healthcare, Inc. | 09/10/2026SE |
| K254000 | Happy Health Blood Pressure MonitorDXN · Traditional | Happy Health, Inc. | 09/03/2026SE |
| K262658 | Automatic Digital Blood Pressure monitor (LD-526)DXN · Special | Honsun (Nantong) Co., Ltd. | 08/31/2026SE |
| K261394 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus…DXN · Traditional | JOYTECH Healthcare Co., Ltd. | 08/26/2026SE |
| K261061 | BP Go (BPP-855)DXN · Traditional | Wellvii, Inc. | 08/13/2026SE |
| K253425 | Arm-type Fully Automatic Digital Blood Pressure Monitor…DXN · Traditional | Joytech Healthcare Co. , Ltd. | 08/13/2026SE |
| K261136 | Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)DXN · Traditional | Guangzhou Daxin Health Technology Co., Ltd. | 07/23/2026SE |
| K261082 | Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)DXN · Traditional | Microlife Corporation | 07/23/2026SE |
| K253126 | Wrist Blood Pressure Monitor (XW-05)DXN · Traditional | Shenzhen Ziqing Medical Equipment Co., Ltd. | 06/18/2026SE |
| K260693 | VicorderCS (VCS-SYS-1100)DXN · Traditional | 80 Beats Medical GmbH | 06/16/2026SE |
More from 80 Beats Medical GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K954962 | Spacelabs Medical Multigas AnalyzerCBR · Traditional | 05/31/1996SE |
| K951605 | Spacelabs Medical Casemaster Information Management SystemDSH · Traditional | 07/14/1995SE |
| K950779 | Heart Rate Variability Software OptionDPS · Traditional | 04/25/1995SE |
| K941165 | Comet Capnograph ModuleCCK · Traditional | 10/06/1994SE |
| K923788 | Space Labs Model 90560LOS · Traditional | 12/06/1993SE |
| K912742 | Esophageal Stethoscope Temperature ProbeFLL · Traditional | 04/20/1992SE |
| K913038 | Spacelab Model 90845 PCMS Multidisclosure StationDSH · Traditional | 10/04/1991SE |
| K905065 | Defibrillator Lead AdapterLDD · Traditional | 04/12/1991SE |
| K910029 | Patient Care Management System ModificationDXK · Traditional | 01/31/1991SE |
| K896903 | First Medic Model 510LDD · Traditional | 12/27/1990SE |
Questions and answers
When was Local Report Generator cleared by the FDA?
Local Report Generator (K904318) received a 510(k) decision of Substantially Equivalent on December 18, 1990, 89 days after the submission was received.
What is the product code of K904318?
The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.