The following data is part of a premarket notification filed by Center Laboratories, Inc. with the FDA for Rhinomanometer A440 Digital.
| Device ID | K844230 |
| 510k Number | K844230 |
| Device Name: | RHINOMANOMETER A440 DIGITAL |
| Classification | Rhinoanemometer (measurement Of Nasal Decongestion) |
| Applicant | CENTER LABORATORIES, INC. 35 CHANNEL DR. Port Washington, NY 11050 |
| Contact | Jerry D Oliver |
| Correspondent | Jerry D Oliver CENTER LABORATORIES, INC. 35 CHANNEL DR. Port Washington, NY 11050 |
| Product Code | BXQ |
| CFR Regulation Number | 868.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-01 |
| Decision Date | 1984-11-27 |