The following data is part of a premarket notification filed by E. Benson Hood Lab, Inc. with the FDA for Eccovision Acoustic Diagnostic Imaging Acoustic Pharyngometer.
| Device ID | K011329 |
| 510k Number | K011329 |
| Device Name: | ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETER |
| Classification | Rhinoanemometer (measurement Of Nasal Decongestion) |
| Applicant | E. BENSON HOOD LAB, INC. 575 WASHINGTON ST. Pembroke, MA 02359 |
| Contact | Lewis Marten |
| Correspondent | Lewis Marten E. BENSON HOOD LAB, INC. 575 WASHINGTON ST. Pembroke, MA 02359 |
| Product Code | BXQ |
| CFR Regulation Number | 868.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-01 |
| Decision Date | 2002-07-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860719000339 | K011329 | 000 |