The following data is part of a premarket notification filed by Multigon Industries, Inc. with the FDA for Pocket Transcranial And Vascular Doppler Spectrum Analyzer, Model 500p; Pw Doppler Ultraound Probe, Model 2mpb..
| Device ID | K051739 |
| 510k Number | K051739 |
| Device Name: | POCKET TRANSCRANIAL AND VASCULAR DOPPLER SPECTRUM ANALYZER, MODEL 500P; PW DOPPLER ULTRAOUND PROBE, MODEL 2MPB. |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | MULTIGON INDUSTRIES, INC. ONE ODELL PLAZA Yonkers, NY 10701 |
| Contact | William Stern |
| Correspondent | William Stern MULTIGON INDUSTRIES, INC. ONE ODELL PLAZA Yonkers, NY 10701 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-28 |
| Decision Date | 2005-07-28 |
| Summary: | summary |