The following data is part of a premarket notification filed by Melville Software Ltd. with the FDA for Mmc Amplifier.
Device ID | K943673 |
510k Number | K943673 |
Device Name: | MMC AMPLIFIER |
Classification | Amplifier, Physiological Signal |
Applicant | MELVILLE SOFTWARE LTD. 350 SPARKS ST. SUITE 1007 Ottawa, Ontario, CA K1r 7s8 |
Contact | Tom Anderson |
Correspondent | Tom Anderson MELVILLE SOFTWARE LTD. 350 SPARKS ST. SUITE 1007 Ottawa, Ontario, CA K1r 7s8 |
Product Code | GWL |
CFR Regulation Number | 882.1835 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-07-26 |
Decision Date | 1994-10-26 |