Wrist Blood Pressure Meter Model SE-330
FDA 510(k) K973078 · Sein Electronics Co., Ltd.
510(k) numberK973078
Submission
- Device name
- Wrist Blood Pressure Meter Model SE-330
- Applicant
- Sein Electronics Co., Ltd.
Mahwah, NJ, US - Received
- August 18, 1997
- Decision date
- May 20, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DPW – Flowmeter, Blood, Cardiovascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2100
- Specialty
- Cardiovascular
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More from Remington Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K052108 | Sein Blood Glucose and Blood Pressure Monitor System, Model BGP-100NBW · Abbreviated | 12/07/2005SE |
| K042138 | Full Auto Wrist Digital Blood Pressure Monitor Model# SE-311DXN · Special | 08/24/2004SE |
| K042014 | Digital Blood Pressure Monitor, Models SE-9000, SE-9200 and SE-9400DXN · Special | 08/06/2004SE |
| K032927 | Full Auto Arm Digital Blood Pressure MonitorDXN · Traditional | 05/07/2004SE |
| K012054 | Full Auto Wrist Digital Blood Pressure Monitor, Model SE-312DXN · Traditional | 08/08/2001SE |
| K003711 | Ambulatory Blood Pressure Monitoring System, Model SE-25M/25PDXN · Traditional | 12/15/2000SE |
| K003282 | Full Auto Blood Pressure Monitor, Model SE-7700HDXN · Traditional | 11/01/2000SE |
| K991397 | Transcutaneous Electrical Nerve Stimulator SE-30 TENSGZJ · Traditional | 02/11/2000SE |
| K952827 | Full Auto Wrist Blood Pressure Meter Model SE-5000DXN · Traditional | 11/14/1996SE |
| K952826 | Full Auto Fuzzy Blood Pressure Meter Model SE-7000DXN · Traditional | 11/14/1996SE |
Questions and answers
When was Wrist Blood Pressure Meter Model SE-330 cleared by the FDA?
Wrist Blood Pressure Meter Model SE-330 (K973078) received a 510(k) decision of Substantially Equivalent on May 20, 1999, 640 days after the submission was received.
What is the product code of K973078?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.