The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Acon Automatic Blood Pressure Monitor Kit, Model Ob11-111, W/ac Adapter, Model Ob11-112.
| Device ID | K060925 |
| 510k Number | K060925 |
| Device Name: | ACON AUTOMATIC BLOOD PRESSURE MONITOR KIT, MODEL OB11-111, W/AC ADAPTER, MODEL OB11-112 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | ACON LABORATORIES, INC. 4108 SORRENTO VALLEY BLVD. San Diego, CA 92121 |
| Contact | Edward Tung |
| Correspondent | Edward Tung ACON LABORATORIES, INC. 4108 SORRENTO VALLEY BLVD. San Diego, CA 92121 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-04 |
| Decision Date | 2006-05-09 |
| Summary: | summary |