The following data is part of a premarket notification filed by Associated Mills, Inc. with the FDA for Pollenex Digital Sphygmomanometer Bp-4000.
| Device ID | K844397 |
| 510k Number | K844397 |
| Device Name: | POLLENEX DIGITAL SPHYGMOMANOMETER BP-4000 |
| Classification | Computer, Blood-pressure |
| Applicant | ASSOCIATED MILLS, INC. 165 NORTH CANAL ST. Chicago, IL 60606 |
| Contact | Gerald J Rossier |
| Correspondent | Gerald J Rossier ASSOCIATED MILLS, INC. 165 NORTH CANAL ST. Chicago, IL 60606 |
| Product Code | DSK |
| CFR Regulation Number | 870.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-13 |
| Decision Date | 1985-04-18 |