The following data is part of a premarket notification filed by Advanced Instrumentations, Inc. with the FDA for Pd-100 Series Ultrasonic Pocket Doppler.
| Device ID | K111934 |
| 510k Number | K111934 |
| Device Name: | PD-100 SERIES ULTRASONIC POCKET DOPPLER |
| Classification | Monitor, Ultrasonic, Fetal |
| Applicant | ADVANCED INSTRUMENTATIONS, INC. 601 WEST 20 ST Hialeah, FL 33010 |
| Contact | Jorge Millan |
| Correspondent | Jorge Millan ADVANCED INSTRUMENTATIONS, INC. 601 WEST 20 ST Hialeah, FL 33010 |
| Product Code | KNG |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-08 |
| Decision Date | 2011-09-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B510PD100PRO1 | K111934 | 000 |
| B510PD1000PRO1 | K111934 | 000 |