The following data is part of a premarket notification filed by Wenzhou Longwan Medical Instrument Company with the FDA for As101, Blood Pressure Cuff.
| Device ID | K060871 |
| 510k Number | K060871 |
| Device Name: | AS101, BLOOD PRESSURE CUFF |
| Classification | Blood Pressure Cuff |
| Applicant | WENZHOU LONGWAN MEDICAL INSTRUMENT COMPANY 340 SHADY GROVE ROAD Flintville, TN 37335 |
| Contact | Charlie Mack |
| Correspondent | Charlie Mack WENZHOU LONGWAN MEDICAL INSTRUMENT COMPANY 340 SHADY GROVE ROAD Flintville, TN 37335 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-30 |
| Decision Date | 2006-06-09 |
| Summary: | summary |