The following data is part of a premarket notification filed by Advanced Instruments, Inc. with the FDA for Osmometer Model 110.
Device ID | K873642 |
510k Number | K873642 |
Device Name: | OSMOMETER MODEL 110 |
Classification | Osmometer For Clinical Use |
Applicant | ADVANCED INSTRUMENTS, INC. 1000 HIGHLAND AVE. Needham Heights, MA 02194 |
Contact | Douglas Guerette |
Correspondent | Douglas Guerette ADVANCED INSTRUMENTS, INC. 1000 HIGHLAND AVE. Needham Heights, MA 02194 |
Product Code | JJM |
CFR Regulation Number | 862.2730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-09 |
Decision Date | 1987-10-20 |