Sanaphon N
by Rudolf Riester GmbH & Co. KG
510(k) K972378
Sanaphon N is a Class II device made by Rudolf Riester GmbH & Co. KG, cleared under FDA 510(k) K972378 on 24 Sep 1997, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK972378 | Date24 Sep 1997 | StatusActive |
Official records
- FDA 510(k) database K972378
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DXQ
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1120
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code DXQ (Blood Pressure Cuff).
- Blood Pressure Cuff, U1883S, U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, Blood Pressure Cuff, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, Blood Pressure Cuff, U1710S, U1720S, U1730S, U1740S, U1750S, U1760S, Blood Pressure Cuff, U1770S, U1790s, U1710D, U1720D, U1730D, U1740D by Jkh USA, LLC
- Disposable Blood Pressure cuff; Reusable Blood Pressure cuff by SHENZHEN MEDKE TECHNOLOGY CO., LTD.
- DISPOSABLE BLOOD PRESSURE CUFF by Wuxi Medical Instrument Factory
- CRITIKON SOFT BLOOD PRESSURE CUFF by Johnson & Johnson Medical, Inc.
- TYTAN BLOOD PRESSURE CUFF by Tytan Medical Corp.
- Diagnostix™ 805NWA by American Diagnostic Corporation
- MDF® MDF840D11 by MDF Instruments Medifriend Inc.
- SLIMLINE 3000 by Pymah Corp.
- ALL PURPOSE CUFF, MODEL 222APC by SunTech Medical, Inc
- TRICOT BLOOD PRESSURE CUFF by Ya Horng Electronic Co., Ltd.