The following data is part of a premarket notification filed by Foley & Lardner with the FDA for Ch-611b And Ch-611c Digital Wrist Sphygmomanometers Blood Pressure Meter.
| Device ID | K973613 |
| 510k Number | K973613 |
| Device Name: | CH-611B AND CH-611C DIGITAL WRIST SPHYGMOMANOMETERS BLOOD PRESSURE METER |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | FOLEY & LARDNER 3000 K STREET, N.W. SUITE 500 Washington, DC 20007 -5109 |
| Contact | Joseph D Edmondson Jr. |
| Correspondent | Joseph D Edmondson Jr. FOLEY & LARDNER 3000 K STREET, N.W. SUITE 500 Washington, DC 20007 -5109 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-22 |
| Decision Date | 1998-04-14 |
| Summary: | summary |