The following data is part of a premarket notification filed by Rudolf Riester Gmbh with the FDA for Oscillometric Blood Pressure Monitor.
Device ID | K190927 |
510k Number | K190927 |
Device Name: | Oscillometric Blood Pressure Monitor |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | Rudolf Riester GmbH P.O. Box 35 Bruckstrasse 31 Jungingen, DE D-72417 |
Contact | Vivi Ding |
Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-04-09 |
Decision Date | 2019-06-24 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04045396214590 | K190927 | 000 |
04045396208971 | K190927 | 000 |
04045396208858 | K190927 | 000 |
04045396208797 | K190927 | 000 |