The following data is part of a premarket notification filed by Multigon Industries, Inc. with the FDA for Model 500a Vascular Spectrum Analyzer W/doppler.
| Device ID | K881263 | 
| 510k Number | K881263 | 
| Device Name: | MODEL 500A VASCULAR SPECTRUM ANALYZER W/DOPPLER | 
| Classification | Transducer, Ultrasonic, Obstetric | 
| Applicant | MULTIGON INDUSTRIES, INC. P.O. BOX 2485 Mt. Vernon, NY 10551 | 
| Contact | William Stern | 
| Correspondent | William Stern MULTIGON INDUSTRIES, INC. P.O. BOX 2485 Mt. Vernon, NY 10551 | 
| Product Code | HGL | 
| CFR Regulation Number | 884.2960 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1988-03-24 | 
| Decision Date | 1990-01-05 |