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 |