The following data is part of a premarket notification filed by Biomedical Dynamics, Inc. with the FDA for Aneroid Blood Pressure Gauge.
| Device ID | K904376 |
| 510k Number | K904376 |
| Device Name: | ANEROID BLOOD PRESSURE GAUGE |
| Classification | Bulb, Inflation, For Endoscope |
| Applicant | BIOMEDICAL DYNAMICS, INC. 12250 NICOLLET AVE. Burnsville, MN 55337 |
| Contact | Matthew Bellin |
| Correspondent | Matthew Bellin BIOMEDICAL DYNAMICS, INC. 12250 NICOLLET AVE. Burnsville, MN 55337 |
| Product Code | FCY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-25 |
| Decision Date | 1990-12-20 |