The following data is part of a premarket notification filed by Hangzhou Reli-on Co., Ltd with the FDA for Blood Pressure Monitor With Stethoscope.
Device ID | K122259 |
510k Number | K122259 |
Device Name: | BLOOD PRESSURE MONITOR WITH STETHOSCOPE |
Classification | Blood Pressure Cuff |
Applicant | HANGZHOU RELI-ON CO., LTD 77325 JOYCE WAY Echo, OR 97826 |
Contact | Charile Mack |
Correspondent | Charile Mack HANGZHOU RELI-ON CO., LTD 77325 JOYCE WAY Echo, OR 97826 |
Product Code | DXQ |
CFR Regulation Number | 870.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-07-27 |
Decision Date | 2012-09-24 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10810132041454 | K122259 | 000 |
10810132041447 | K122259 | 000 |
10810132041430 | K122259 | 000 |
10810132041423 | K122259 | 000 |