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 |
| M368100040BK1 | K122259 | 000 |
| M368100040BUR1 | K122259 | 000 |
| M368100040DB1 | K122259 | 000 |
| M368100040GRP1 | K122259 | 000 |
| M368100040HG1 | K122259 | 000 |
| M368100040ORC1 | K122259 | 000 |
| M368100040P1 | K122259 | 000 |
| M3681005101 | K122259 | 000 |
| 10810132041423 | K122259 | 000 |
| 10810132041430 | K122259 | 000 |
| 10810132041447 | K122259 | 000 |
| M368100001N1 | K122259 | 000 |