The following data is part of a premarket notification filed by Acoustic Imaging Technologies Corp. with the FDA for Color Doppler Option To Ai 5200 Diag Ultraso Syst.
| Device ID | K910212 |
| 510k Number | K910212 |
| Device Name: | COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYST |
| Classification | Knife, Ear |
| Applicant | ACOUSTIC IMAGING TECHNOLOGIES CORP. 10027 SOUTH 15ST ST. Phoenix, AZ 85044 |
| Contact | Lori Cadwell |
| Correspondent | Lori Cadwell ACOUSTIC IMAGING TECHNOLOGIES CORP. 10027 SOUTH 15ST ST. Phoenix, AZ 85044 |
| Product Code | JYO |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-15 |
| Decision Date | 1991-07-11 |